Identifying Optimal Smoking Cessation Intervention Components (Cessation)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Dean Health System
Mercy Health System, Wisconsin
Aurora Health Care
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01116986
First received: April 27, 2010
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

The goal of this research is to identify the best smoking cessation intervention components to be combined into a state-on-the-art, comprehensive smoking cessation intervention. This research examines the ability of different interventions, provided both prior to and after the quit attempt, to maximize the ability to initially quit and then stay quit. The investigators will be examining six different treatment interventions: pre-quit nicotine patch, pre-quit nicotine gum, pre-quit counseling, post-quit in-person counseling, post-quit phone counseling and duration of post-quit nicotine replacement therapy.


Condition Intervention Phase
Smoking
Smoking Cessation
Nicotine
Behavioral: Counseling before quit attempt
Behavioral: Minimal In-person counseling during quit attempt
Behavioral: Intensive in-person counseling during the quit attempt
Behavioral: Minimal phone counseling during the quit attempt
Behavioral: Intensive phone counseling during the quit attempt
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt
Drug: Pre-Quit Nicotine Gum
Drug: Pre-Quit Nicotine Patch
Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Project 2: Identifying Optimal Smoking Cessation Intervention Components

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Latency to Relapse [ Time Frame: During the first 6 months post-quit ] [ Designated as safety issue: No ]
    Latency to Relapse during the first 6 months post-quit, with relapse defined as 7 consecutive days of smoking; this outcome will be analyzed in a Cox regression survival analysis model with non-relapsers coded as right-censored.


Secondary Outcome Measures:
  • 7-day point prevalence abstinence [ Time Frame: Assessed at weeks 8, 16, and 26 post-quit. ] [ Designated as safety issue: No ]
    7-day point prevalence abstinence (PPA) assessed at weeks 8, 16, and 26; 7-day PPA assesses whether or not a participant reported smoking at all on any of the 7 days prior to the follow-up timepoint (weeks 8, 16, and 26); coded as 0=no smoking on any of the 7 days, 1=smoking on one or more of the 7 days; this binary outcome will be analyzed longitudinally in a Generalized Linear Mixed Model (GLMM).


Enrollment: 637
Study Start Date: June 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk

This arm of the project will address the following question:

How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

Behavioral: Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Behavioral: Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Behavioral: Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.

Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum

If randomized to both the Prequit Patch and Prequit Gum Conditions:

Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.

Experimental: 2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk

This arm of the project will address the following question:

How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

Behavioral: Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Behavioral: Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Behavioral: Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.

Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum

If randomized to both the Prequit Patch and Prequit Gum Conditions:

Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.

Experimental: 3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk

This arm of the project will address the following question:

How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

Behavioral: Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Behavioral: Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Behavioral: Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.

Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum

If randomized to both the Prequit Patch and Prequit Gum Conditions:

Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.

Experimental: 4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk

This arm of the project will address the following question:

How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

Behavioral: Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Behavioral: Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Behavioral: Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.

Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum

If randomized to both the Prequit Patch and Prequit Gum Conditions:

Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.

Experimental: 5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk

This arm of the project will address the following question:

How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

Behavioral: Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Behavioral: Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.

Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum

If randomized to both the Prequit Patch and Prequit Gum Conditions:

Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.

Experimental: 6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk

This arm of the project will address the following question:

How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

Behavioral: Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Behavioral: Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.

Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum

If randomized to both the Prequit Patch and Prequit Gum Conditions:

Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.

Experimental: 7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk

This arm of the project will address the following question:

How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

Behavioral: Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Behavioral: Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.

Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum

If randomized to both the Prequit Patch and Prequit Gum Conditions:

Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.

Experimental: 8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk

This arm of the project will address the following question:

How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

Behavioral: Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Behavioral: Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.

Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum

If randomized to both the Prequit Patch and Prequit Gum Conditions:

Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.

Experimental: 9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk

This arm of the project will address the following question:

How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

Behavioral: Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Behavioral: Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Behavioral: Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.

Drug: Pre-Quit Nicotine Patch

If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):

Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.

Experimental: 10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk

This arm of the project will address the following question:

How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

Behavioral: Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Behavioral: Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Behavioral: Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.

Drug: Pre-Quit Nicotine Patch

If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):

Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.

Experimental: 11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk

This arm of the project will address the following question:

How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

Behavioral: Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Behavioral: Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Behavioral: Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.

Drug: Pre-Quit Nicotine Patch

If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):

Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.

Experimental: 12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk

This arm of the project will address the following question:

How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

Behavioral: Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Behavioral: Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Behavioral: Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.

Drug: Pre-Quit Nicotine Patch

If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):

Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.

Experimental: 13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk

This arm of the project will address the following question:

How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

Behavioral: Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Behavioral: Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.

Drug: Pre-Quit Nicotine Patch

If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):

Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.

Experimental: 14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk

This arm of the project will address the following question:

How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

Behavioral: Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Behavioral: Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.

Drug: Pre-Quit Nicotine Patch

If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):

Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.

Experimental: 15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk

This arm of the project will address the following question:

How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

Behavioral: Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Behavioral: Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.

Drug: Pre-Quit Nicotine Patch

If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):

Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.

Experimental: 16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk

This arm of the project will address the following question:

How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

Behavioral: Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Behavioral: Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.

Drug: Pre-Quit Nicotine Patch

If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):

Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.

Experimental: 17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk

This arm of the project will address the following question:

How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

Behavioral: Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Behavioral: Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Behavioral: Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.

Drug: Pre-Quit Nicotine Gum

If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):

Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.

Experimental: 18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk

This arm of the project will address the following question:

How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

Behavioral: Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Behavioral: Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Behavioral: Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.

Drug: Pre-Quit Nicotine Gum

If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):

Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.

Experimental: 19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk

This arm of the project will address the following question:

How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

Behavioral: Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Behavioral: Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Behavioral: Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.

Drug: Pre-Quit Nicotine Gum

If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):

Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.

Experimental: 20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Behavioral: Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Behavioral: Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Behavioral: Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.

Drug: Pre-Quit Nicotine Gum

If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):

Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.

Experimental: 21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk

This arm of the project will address the following question:

How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

Behavioral: Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Behavioral: Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.

Drug: Pre-Quit Nicotine Gum

If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):

Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.

Experimental: 22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk

This arm of the project will address the following question:

How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

Behavioral: Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Behavioral: Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.

Drug: Pre-Quit Nicotine Gum

If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):

Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.

Experimental: 23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk

This arm of the project will address the following question:

How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

Behavioral: Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Behavioral: Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.

Drug: Pre-Quit Nicotine Gum

If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):

Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.

Experimental: 24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk

This arm of the project will address the following question:

How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

Behavioral: Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Behavioral: Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.

Drug: Pre-Quit Nicotine Gum

If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):

Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.

Experimental: 25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk

This arm of the project will address the following question:

How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

Behavioral: Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Behavioral: Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Behavioral: Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.

Experimental: 26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk

This arm of the project will address the following question:

How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

Behavioral: Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Behavioral: Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Behavioral: Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.

Experimental: 27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk

This arm of the project will address the following question:

How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

Behavioral: Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Behavioral: Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Behavioral: Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.

Experimental: 28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk

This arm of the project will address the following question:

How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

Behavioral: Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Behavioral: Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Behavioral: Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.

Experimental: 29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16

This arm of the project will address the following question:

How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

Behavioral: Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Behavioral: Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.

Experimental: 30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W

This arm of the project will address the following question:

How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

Behavioral: Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Behavioral: Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.

Experimental: 31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W

This arm of the project will address the following question:

How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt

Behavioral: Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Behavioral: Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.

Experimental: 32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16

This arm of the project will address the following question:

How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

Behavioral: Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Behavioral: Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

If randomized to this condition:

After the target quit day:

Patch:

IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.

IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.

Gum:

IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older;
  • Report smoking at least 5 cigarettes per day for the previous 6 months;
  • Able to read and write English;
  • Agree to attend visits, to respond to coaching calls, and to respond to Interactive Voice Response (IVR) phone prompts;
  • Plans to remain in the intervention catchment area for at least 12 months;
  • Currently interested in quitting smoking (defined as would like to try to quit in the next 30 days).
  • All women of childbearing potential will be required to agree to use an acceptable method of birth control to prevent pregnancy during the study.

Exclusion Criteria:

  • Currently taking bupropion, Wellbutrin, chantix or varenicline (current use of NRT is not exclusionary if the participant agrees to use only study medication for the duration of the study);
  • Study candidate is pregnant, trying to get pregnant, or nursing.
  • A history of psychosis or bipolar disorder
  • A history of skin or allergic reactions while using a nicotine patch.
  • Had a heart attack, stroke, or abnormal electrocardiogram within the past 4 weeks.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116986

Locations
United States, Wisconsin
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, United States, 53711
Sponsors and Collaborators
University of Wisconsin, Madison
Dean Health System
Mercy Health System, Wisconsin
Aurora Health Care
Investigators
Study Director: Megan E Piper, PhD University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Principal Investigator: Timothy B Baker, PhD University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
  More Information

Additional Information:
No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01116986     History of Changes
Other Study ID Numbers: H-2009-0204, 9P50CA143188
Study First Received: April 27, 2010
Last Updated: May 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Smoking
Smoking Cessation
Nicotine

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014