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Group Therapy for Nicotine Dependence: Mindfulness and Smoking

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00297479
First received: February 24, 2006
Last updated: May 27, 2014
Last verified: May 2014
  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:


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 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 2016
Estimated Primary Completion Date: February 2016 (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:

  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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
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, NCI-2012-02081
Study First Received: February 24, 2006
Last Updated: May 27, 2014
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:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014