Group Therapy for Nicotine Dependence: Mindfulness and Smoking
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Smoking Tobacco Use Cessation |
Behavioral: MBAT Group Therapy Drug: Nicotine Behavioral: Group Therapy Behavioral: Individual Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Group Therapy for Nicotine Dependence |
- Abstinence Rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 750 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
|
|
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
|
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
|
|
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
|
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
|
Detailed 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:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: David Wetter, Ph.D. | 713-745-2682 |
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77230 | |
| Principal Investigator: David W Wetter, Ph.D. | |
| Principal Investigator: | David W Wetter, Ph.D. | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00297479 History of Changes |
| Other Study ID Numbers: | 2004-0988, R01DA018875 |
| Study First Received: | February 24, 2006 |
| Last Updated: | November 19, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Tobacco Cessation Smoking Cessation |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Smoking Substance-Related Disorders Mental Disorders Habits Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013