View Clinical Trial (Medical Research Study)
Group Therapy for Nicotine Dependence
| City: |
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Houston |
| State: |
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Texas |
| Zip Code: |
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77230 |
| Conditions: |
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Smoking - Tobacco Use Cessation |
| Purpose: |
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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.
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| Study Summary: |
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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:
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.
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| Criteria: |
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Inclusion Criteria:
1. Age 18 or above
2. Current smoker with a history of at least five cigarettes/day for the past year
3. Motivated to quit within the next 30 days (preparation stage)
4. Participants must provide a viable home address and a functioning home telephone
number
5. Can read and write in English
6. Register "8" or more on a carbon monoxide breath test
7. Provide viable collateral contact information
Exclusion Criteria:
1. Contraindication for nicotine patch use
2. Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless
tobacco)
3. Use of bupropion or nicotine patch replacement products other than the study patches
4. Pregnancy or lactation
5. Another household member enrolled in the study
6. Active substance dependence (exclusive of nicotine dependence)
7. Current psychiatric disorder; current use of psychotropic medication
8. Participation in a smoking cessation program or study during the past 90 days
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| NCT ID: |
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NCT00297479 |
| Primary Contact: |
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Principal Investigator
David W Wetter, Ph.D.
UT MD Anderson Cancer Center
David Wetter, Ph.D.
Phone: 713-745-2682
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| Backup Contact: |
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N/A |
| Location Contact: |
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Houston, Texas 77230
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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