Group Therapy for Nicotine Dependence: Mindfulness and Smoking

Study Overview
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Brief Summary
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The goal of this behavioral research study is to create and study a Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence. Mindfulness is a method to help focus attention on being in the here and now. It can be learned through training in how to control one's attention. It is usually taught through meditation. The overarching goals of the study are to evaluate the efficacy of MBAT for nicotine dependence and the mechanisms and effects posited to mediate MBAT's impact on abstinence.

Detailed Description
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This 3-group randomized clinical trial will develop and evaluate a Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence. Mindfulness reflects a purposeful control of attention and can be learned through training in attentional control procedures. Current cigarette smokers (N=550; 400 in formal study; up to 80-150 pilot) will be randomly assigned to Usual Care (UC), Standard Treatment (ST) or MBAT. UC will be four 5-10 minute counseling sessions following the problem-solving approach in the Treating Tobacco Use and Dependence Clinical Practice Guideline (Guideline). ST is a standard smoking cessation group program using a problem-solving/coping skills approach. MBAT is a group smoking cessation program derived from Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy. MBAT will not alter the basic mindfulness approach used in MBCT and MBSR, but will replace depression-related material with smoking cessation strategies from the Guideline. All participants will receive nicotine patches and self-help materials. MBAT mechanisms and effects will be assessed using implicit cognitive psychological measures and computer-administered questionnaires. Participants will be tracked from baseline through 4 (UC) or 8 (ST and MBAT) treatment visits and follow-up visits 1 and 23 weeks post-treatment. The overarching goals are to evaluate MBAT's efficacy for nicotine dependence and the mechanisms and effects posited to mediate MBAT's impact on abstinence. Primary specific aims are to: Examine the effects of MBAT on abstinence rates Examine the effects of MBAT on mindfulness/metacognitive awareness, attentional control, smoking automaticity, smoking associations in memory, negative affect, depression, stress, affect regulation expectancies, self-efficacy, withdrawal, and coping across the pre- and post-cessation period, and whether these variables mediate MBAT effects on abstinence.

Official Title
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Group Therapy for Nicotine Dependence

Conditions
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Smoking, Tobacco Use Cessation

Intervention / Treatment
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* Behavioral: MBAT Group Therapy
* Drug: Nicotine
* Behavioral: Group Therapy
* Behavioral: Individual Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or above Current smoker with a history of at least five cigarettes/day for the past year Motivated to quit within the next 30 days (preparation stage) Participants must provide a viable home address and a functioning home telephone number Can read and write in English Register 8 or more on a carbon monoxide breath test Provide viable collateral contact information Exclusion Criteria: Contraindication for nicotine patch use Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco) Use of bupropion or nicotine patch replacement products other than the study patches Pregnancy or lactation Another household member enrolled in the study Active substance dependence (exclusive of nicotine dependence) Current psychiatric disorder; current use of psychotropic medication Participation in a smoking cessation program or study during the past 90 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Treatment Group (MBAT)<br>MBAT is 6 weeks of nicotine patch therapy; a Self-help guide; and In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence. | Behavioral: MBAT Group Therapy<br>* In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence<br>* Other names: counseling;Drug: Nicotine<br>* 6 weeks of nicotine patch therapy<br>* Other names: nicotine patch therapy;|
| Active Comparator: Standard Care Group<br>Standard Care Group (ST) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline | Drug: Nicotine<br>* 6 weeks of nicotine patch therapy<br>* Other names: nicotine patch therapy;Behavioral: Group Therapy<br>* In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline<br>* Other names: counseling;|
| Active Comparator: Usual Care Group<br>Usual Care (UC) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline | Drug: Nicotine<br>* 6 weeks of nicotine patch therapy<br>* Other names: nicotine patch therapy;Behavioral: Individual Therapy<br>* In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline<br>* Other names: counseling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Smoking Abstinence | Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach. | 4 weeks post quit day (one week following the end of treatment) | 
| Smoking Abstinence | Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach | 26 weeks post quit day | 
| Smoking Abstinence | Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach | 4 weeks post quit day (one week following the end of treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco Cessation, Smoking Cessation