Smoking Clinical Trial - Group Therapy for Nicotine Dependence:

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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:

1. Examine the effects of MBAT on abstinence rates

2. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00297479
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact
Status	Completed
Phase	N/A
Start date	April 2005
Completion date	September 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Group Therapy for Nicotine Dependence: Mindfulness and Smoking

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms