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Study Summary
No. 2004-0988:.......Psychosocial......David Wetter......Health Disparities Research
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Study Summary Title
Study Summary
Number:
2004-0988
Study Title:Group Therapy for Nicotine Dependence
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Physician New Patient Referral
Name:David WetterPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Health Disparities ResearchReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-2682
Contact us about clinical trials
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General Information
Disease Group:PsychosocialSupported By:N/A
Phase of Study:N/AReturn
Visit:
Participants will visit M.D. Anderson up to 11 times: a baseline visit; 8
treatment visits for MBAT and ST groups and 4 visits for the UC group; 2
follow-up visits. Pilot participants will visit through the 1st follow-up (10
visits).
Treatment
Agents:
Behavioral Intervention
Nicotine
Home Care:Participants will self apply nicotine patches at home. To minimize missing
abstinence data, we may collect information/samples via telephone, mail, and/or
a visit to participants' home/office if they so choose.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
N/A.
Description/
Intervention:
The goal of this behavioral research study is to create and study a
Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence.
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Study Objectives / Outcomes
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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Study Status Information
Study Activation / Registration Date:04/11/2005
IRB Review and Approval Date:03/16/2005
Study Type:Not Applicable
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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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Links
Registration Number: NCT00297479
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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