Group Therapy for Nicotine Dependence: Mindfulness and Smoking
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| ClinicalTrials.gov Identifier: NCT00297479 |
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Recruitment Status :
Completed
First Posted : February 28, 2006
Results First Posted : June 16, 2020
Last Update Posted : June 16, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Smoking Tobacco Use Cessation | Behavioral: MBAT Group Therapy Drug: Nicotine Behavioral: Group Therapy Behavioral: Individual Therapy | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 650 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Group Therapy for Nicotine Dependence |
| Study Start Date : | April 2005 |
| Actual Primary Completion Date : | September 2016 |
| Actual Study Completion Date : | September 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Mindfulness-Based Treatment Group (MBAT)
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.
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Behavioral: MBAT Group Therapy
In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence
Other Names:
Drug: Nicotine 6 weeks of nicotine patch therapy
Other Name: nicotine patch therapy |
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Active Comparator: Standard Care Group
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
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Drug: Nicotine
6 weeks of nicotine patch therapy
Other Name: nicotine patch therapy Behavioral: Group Therapy In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
Other Name: counseling |
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Active Comparator: Usual Care Group
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
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Drug: Nicotine
6 weeks of nicotine patch therapy
Other Name: nicotine patch therapy Behavioral: Individual Therapy In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
Other Name: counseling |
- Number of Participants With Smoking Abstinence [ Time Frame: 4 weeks post quit day (one week following the end of treatment) ]Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.
- Smoking Abstinence [ Time Frame: 26 weeks post quit day ]Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
- Smoking Abstinence [ Time Frame: 4 weeks post quit day (one week following the end of treatment) ]Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00297479
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | David W Wetter, Ph.D. | M.D. Anderson Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00297479 |
| Other Study ID Numbers: |
2004-0988 R01DA018875 ( U.S. NIH Grant/Contract ) NCI-2012-02081 ( Registry Identifier: NCI CTRP ) |
| First Posted: | February 28, 2006 Key Record Dates |
| Results First Posted: | June 16, 2020 |
| Last Update Posted: | June 16, 2020 |
| Last Verified: | June 2020 |
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Tobacco Cessation Smoking Cessation |
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Tobacco Use Disorder Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Nicotine Ganglionic Stimulants Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |