Evaluation of Treatments to Improve Smoking Cessation Medication Adherence

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:
NCT01120704
First received: May 3, 2010
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

Many smokers fail to take their smoking cessation medication as recommended. This research is designed to identify treatments that improve the use of cessation medications and to determine whether an increase in medication use results in increased cessation success. This research will also identify treatments that help people stay quit after a quit attempt and will pioneer more efficient research methods.


Condition Intervention Phase
Smoking
Smoking Cessation
Adherence
Nicotine
Motivation
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
Behavioral: Intensive Maintenance Counseling
Behavioral: Cognitive Medication Adherence Counseling (C-MAC)
Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
Behavioral: Automated Adherence Prompting Phone Calls
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 3: Identifying Optimal Strategies of Increasing Smokers' Adherence to Cessation Medications

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Point prevalence abstinence [ Time Frame: Assessed at 6-months (Week 26) and 1 year (52 weeks) after quit day ] [ Designated as safety issue: No ]
    Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day (collected during follow-up calls at 6 months [Weeks 26] and 1 year [52 weeks] after the target quit day).


Secondary Outcome Measures:
  • Continuous abstinence [ Time Frame: Assessed for 52 weeks after the target quit day. ] [ Designated as safety issue: No ]
    Defined as self-reported total abstinence (using time-line follow-back methods) from any tobacco use, even a single puff, from the target quit day to the specific end point (e.g., 1 week after the target quit day, 8 weeks after the target quit day, 6 months after the target quit day, 1 year after the target quit day). Timeline follow-back for abstinence will be assessed during all visits at Weeks 1, 4, and 8 after the target quit day, and over the phone at Weeks 16, 26, 39, and 52 after the target quit day.

  • Point prevalence abstinence [ Time Frame: Assessed at different time points through 39 weeks after the quit day ] [ Designated as safety issue: No ]
    Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day (collected during all visits at Weeks 1, 4, 8, and 16 after the target quit day, and at follow-up calls at Weeks 16 and 39 after the target quit day).

  • Prolonged Abstinence [ Time Frame: Assessed at 52 weeks after the quit day ] [ Designated as safety issue: No ]
    No self-reported smoking or other tobacco use from 7 days after the target quit day to the specified follow-up time-point (e.g., prolonged 2-month, 6-month, or 1 year abstinence). Tobacco use during the first week after the quit day will not be counted as a violation of prolonged abstinence.

  • Initial Cessation [ Time Frame: Assessed at 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.

  • Withdrawal Trajectories [ Time Frame: Assessed at 52 weeks after the target quit day. ] [ 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.

  • Abstinence Days [ Time Frame: Assessed at 14 days post quit ] [ Designated as safety issue: No ]
    Abstinent days refers to the number of days participants were abstinent during the first 2 weeks following their target quit date

  • Number of days to lapse and relapse [ Time Frame: assessed at 52 weeks post quit ] [ Designated as safety issue: No ]
    The number of days to lapse is defined as the number of days from the target quit day 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 (as reported by the participant). This will be assessed through 52 weeks after the target quit day.

  • Medication Adherence [ Time Frame: Assessed for 26 weeks (depending on the condition) after the target quit day. ] [ Designated as safety issue: No ]
    We will integrate multiple adherence measures: electronic medication monitoring device (Helping Hand) data, used nicotine patch sleeves, automated phone call and questionnaire data to assess medication adherence. In Visits 2-5 we will: 1) download Helping Hand data to assess removing the blister pack of gum from the medication monitor; 2) count used patch sleeves, and 3) collect self-report data to assess gum adherence over the past 7 days and patch adherence using time-line follow-back since prior contact.


Estimated Enrollment: 544
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: Medication Duration during quit attempt

This arm of the project will address the following question:

Does 8 weeks of nicotine patch plus nicotine gum, compared to 26 weeks of nicotine patch plus nicotine gum use increase cessation success?

Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)

IF participant smokes >9 cigs/day AND is randomized to a 8 week condition: they will be asked to take one 21 mg patch/day for 4 weeks, THEN one 14 mg patch/day for 2 weeks, THEN one patch 7mg/day for 2 weeks.Participants will also be asked to use 4-mg gum every 1-2 hours (9 pieces maximum per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.

IF participant smokes 5-9 cigs/day AND is randomized to the 8 week medication condition: they will be asked to take one 14 mg patch/day for 4 weeks, THEN one 7 mg patch/day for 4 weeks. Participants will also be asked to use 2-mg gum every 1-2 hours (9 pieces max per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.

Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)

IF the participant smokes >9 cigs/day AND is randomized to a 26 week medication condition: they will be asked to take one 21 mg patch per day for 22 weeks, THEN one 14 mg patch per day for 2 weeks, THEN one patch 7 mg patch per day for 2 weeks. Participants will also be asked to use one piece of one 4-mg- gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.

IF the participant smokes 5-9 cigs/day AND is randomized to a 26 week medication condition: they will be asked to take one 14 mg patch per day for 22 weeks, THEN one patch 7 mg patch per day for 4 weeks. Participants will also be asked to use one piece of 2-mg gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.

Experimental: Counseling

This arm of the project will address the following question:

Do additional sessions of maintenance counseling improve cessation success relative to the standard Cessation Counseling Common to all participants?

Behavioral: Intensive Maintenance Counseling
Participants randomized to this condition will receive eight 15-minute phone counseling sessions at Weeks 3, 4, 6, 8, 10, 14, 18 & 22. The counseling will encourage continued practice of coping skills, and avoidance of danger situations. Another emphasis will be the continued provision of social support as a means of enhancing motivation. Participants who have relapsed will receive counseling aimed at motivating and planning renewed quit attempts. Other aims are enhancing motivation, especially competence self-appraisals, providing intratreatment support, and encouraging pleasurable activities.
Experimental: Automated Medication Adherence Calls

This arm of the project will address the following question:

Do automated medication adherence promoting phone calls versus no prompting calls increase cessation success?

Behavioral: Automated Adherence Prompting Phone Calls

Participants in this condition will receive fully automated prompts with messages designed to encourage participants to take their medication.

Adherence prompting calls will occur two times in the first week of the quit attempt, and then once a week in weeks 2, 3, 4, 5, and 7. Those in the 26-Week medication condition who are assigned to the active adherence prompting calls intervention, will receive one prompting call a week during Weeks 11, 15, 19 & 23.

Experimental: Electronic Medication Monitoring Device + Feedback

All participants will be given an electronic medication monitor which serves as a container for a blister card of nicotine gum. Each time participants slide the blister card out of the device (presumably to remove a piece of nicotine gum), the device records the time and date.This information can be downloaded and printed.

This arm of the project will address the following question:

Does electronic medication monitoring plus feedback from a coach on one's medication use increase cessation success relative to medication monitoring alone?

Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
If randomized to this condition, the case manager will give patients a computer-generated feedback sheet showing the patient's medication self-administration since the last visit. The case manager will provide problem-solving counseling regarding barriers to medication use. This problem-solving counseling intervention will be given in brief in-person sessions (three in-person sessions for those in the 8 week medication condition and five in-person sessions for those in the 26 week medication condition). Medication monitoring counseling will also occur via phone (two 10-minute sessions for those in the 8 week medication condition and four 10-minute sessions for those in the 26 week medication condition).
Experimental: Cognitive Adherence Intervention

This arm of the project will address the following question:

Does Cognitive Adherence Intervention increase cessation success?

Behavioral: Cognitive Medication Adherence Counseling (C-MAC)
Participants randomized to this condition will be given a brief (10 minute) session of C-MAC treatment at both Visits 1 and 2. C-MAC will include information on NRT such as the following: NRT reduces withdrawal and urges; sustained use reduces the likelihood of relapse; willpower and medication make a good combination; NRT will help a lapsing smoker reachieve abstinence. The tailored counseling component of the CMAC intervention is based on brief evaluation of the smoker's beliefs, concerns, and possible misconceptions about smoking cessation medications.

Detailed Description:

Nonadherent use of smoking cessation medications is very common and highly associated with cessation failure. However, little is presently known about how to improve adherence and whether improved adherence will actually boost cessation success (i.e., its causal role is unknown). This research represents groundbreaking integration of 1) basic theory and data on tobacco dependence, adherence, and intervention mechanisms with 2) the state-of-the-art Intervention Optimization Cycle methodology. This methodology uses factorial designs to efficiently engineer and evaluate intervention components, and to develop an optimal comprehensive treatment package. Participants in Project 3 will be smokers (N = 544) visiting primary care clinics for a regular outpatient visit who, when asked, express an interest in quitting and agree to participate in a smoking cessation research study. The experiment will comprise five experimental factors (2X2X2X2X2), and participants will have a 50% chance of being assigned one of the levels of each factor. The five factors include one medication factor (medication duration: 8 vs. 26 weeks), one counseling factor (maintenance counseling vs. no maintenance counseling), and three adherence factors: 1) Cognitive Medication Adherence Counseling (C-MAC); C-MAC vs. no C-MAC; 2) electronic medication monitoring device (the Helping Hand) + Feedback vs. the medication monitoring device alone; and 3) automated adherence prompting phone calls vs. no prompting.

  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: NCT01120704

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
Principal Investigator: Michael C Fiore, MD, MPH, MBA University of Wisconsin School of Medicine and Public Health, Center for Tobacco Research and Intervention
Study Director: Tanya R Schlam, PhD University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
  More Information

Additional Information:
Publications:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01120704     History of Changes
Other Study ID Numbers: H-2010-0049, 9P50CA143188
Study First Received: May 3, 2010
Last Updated: August 23, 2013
Health Authority: United States: Institutional Review Board

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

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 15, 2014