Group Therapy for Nicotine Dependence: Mindfulness and Smoking - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00297479

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

Resource links provided by NLM:

MedlinePlus related topics: Smoking

Drug Information available for: Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Abstinence Rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Participant involvment 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: therapy counseling 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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297479

Contacts

Contact: David Wetter, Ph.D.

713-745-2682

Locations

United States, Texas
University of Texas MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77230
Principal Investigator: David W Wetter, Ph.D.

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

David W Wetter, Ph.D.

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

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:	May 11, 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 21, 2012