Group Therapy for Nicotine Dependence
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Abstinence Rates
Participant involvement up to 32 weeks. Smoking status questionnaire with biochemical verification. Point-prevalence abstinence at Week 23 is defined as a self-report of no smoking during the previous 7 days and a saliva cotinine level of <20 ng/ml.
5 years
No
David W Wetter, Ph.D.
Principal Investigator
UT MD Anderson Cancer Center
United States: Federal Government
2004-0988
NCT00297479
May 2005
February 2015
Name | Location |
---|---|
University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |