Identifying Optimal Smoking Cessation Intervention Components (Cessation)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Dean Health System
Mercy Health System
Aurora Health Care
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01116986
First received: April 27, 2010
Last updated: April 4, 2013
Last verified: April 2013
  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
Behavioral: Minimal phone counseling after quit date
Behavioral: Intensive phone counseling
Drug: Short Term Nicotine Patch During Quit Attempt
Drug: Long Term Nicotine Patch During Quit Attempt
Drug: Short Term Post-Quit Nicotine Gum
Drug: Long Term Nicotine Gum During Quit Attempt
Drug: Pre-Quit Nicotine Gum
Drug: Pre-Quit Nicotine Patch
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:
  • Abstinent Days [ Time Frame: For the first 14 days post-quit. ] [ Designated as safety issue: No ]
    Abstinent days refers to the number of days the participant was abstinent in during the first 2 weeks following their target quit date.

  • Initial Cessation [ Time Frame: Assessed for the first seven days after the target quit date. ] [ Designated as safety issue: No ]
    Defined as at least 1 day of abstinence during the first 7 days after the target quit day.


Secondary Outcome Measures:
  • Withdrawal Trajectories [ Time Frame: Assessed from the target quit day through 26 weeks PostQuit. ] [ Designated as safety issue: No ]
    Two surveys will measure participant's withdrawal after quitting smoking. We will use a brief version of the Wisconsin Smoking Withdrawal Scale (WSWS) that is 10-items and rated on a 5-point scale where 0="Strongly disagree" and 4="Strongly agree." Positive and Negative Affect Survey (PANAS) assesses affect. In the brief version we will use, participants rate 5 positive and 5 negative emotions on a scale from 1 to 5 based on their feelings in the last 24 hours.

  • Medication Adherence [ Time Frame: Assessed for 8 or 16 weeks (depending on the participant's condition). ] [ Designated as safety issue: No ]
    We will assess medication use prequit and for the first 4 weeks post-quit by counting empty used nicotine patch sleeves, and empty and partially empty nicotine gum blister packs returned by participants. Medication use will also be assessed via nightly phone calls for 3 weeks prequit and 2 weeks post-quit.

  • Continuous abstinence [ Time Frame: Assessed from the target quit day through 26 weeks PostQuit. ] [ Designated as safety issue: No ]
    Defined as self-reported total abstinence from any tobacco use, even a single puff from the target quit day to the specific end point (e.g.. 6 month post target quit day). Abstinence will be assessed using timeline follow-back at 4, 16 and 26 weeks after the target quit day.

  • Prolonged abstinence [ Time Frame: Assessed at each study visit (1 week pre-quit, 1 week, 4 weeks post-quit) and at follow-up contacts (8 weeks, 16 weeks, and 26 weeks post-quit). ] [ Designated as safety issue: No ]
    No smoking or other tobacco use from 7 days after the target quit day to the specific follow-up time-point (e.g. prolonged 6 month abstinence). Tobacco use during the first week after the quit day will not be counted as a violation of prolonged abstinence.

  • Number of days to lapse and relapse [ Time Frame: Assessed from the target quit day through 26 weeks PostQuit. ] [ Designated as safety issue: No ]
    The number of days to lapse is defined as the number of days from the target quit date until the participant reports smoking (even a single puff). The number of days to relapse is defined as the number of days from the target quit day until the first of seven consecutive days of smoking.


Estimated Enrollment: 512
Study Start Date: June 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pre-quit Nicotine Gum

This arm of the project will address the following question:

Does use of pre-quit nicotine gum, compared to no use of nicotine gum prior to the quit day, increase quit attempts, number of abstinent days or abstinence?

Drug: Pre-Quit Nicotine Gum

If randomized to this condition:

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

Experimental: Pre-Quit Nicotine Patch

This arm of the project will address the following question:

Does use of pre-quit nicotine patch, compared to no use of nicotine patch prior to the quit day, increase quit attempts, number of abstinent days or abstinence?

Drug: Pre-Quit Nicotine Patch
Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.
Experimental: Counseling before quit attempt

This arm of the project will address the following question:

Does counseling before quit attempt increase quit attempts, number of abstinent days or abstinence?

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.
Experimental: Medication duration during quit attempt

This arm of the project will address the following question:

Does 16 weeks of combined Nicotine Gum and Nicotine Patch, compared to 8 weeks of combined Nicotine Gum and Nicotine Patch, increase abstinence?

Drug: Short Term Nicotine Patch During Quit Attempt

If randomized into this condition:

After the target quit day:

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

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

Drug: Long Term Nicotine Patch During Quit Attempt

If randomized to this condition:

After the target quit day:

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

Drug: Short Term Post-Quit Nicotine Gum

If randomized to this condition:

After the target quit day:

IF > 10 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 10 cigs/day: ten 2 mg nicotine patch per day for 8 weeks.

Drug: Long Term Nicotine Gum During Quit Attempt

If randomized into this condition:

After the target quit day:

IF > 10 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 10 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.

Experimental: In-person counseling during quit attempt

This arm of the project will address the following question:

Does intensive in-person counseling during a person's quit attempt, relative to minimal in-person counseling increase quit attempts, number of abstinent days or abstinence?

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 in-person counseling
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.
Experimental: Phone Counseling during quit attempt

This arm of the project will address the following question:

Does intensive phone counseling during a person's quit attempt, relative to minimal phone counseling increase quit attempts, number of abstinent days or abstinence?

Behavioral: Minimal phone counseling after quit date
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.
Behavioral: Intensive phone counseling
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.

  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
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
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: April 4, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
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
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014