Group Therapy for Nicotine Dependence: Mindfulness and Smoking

This study is currently recruiting participants.
Verified November 2013 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: November 25, 2013
Last verified: November 2013

February 24, 2006
November 25, 2013
May 2005
February 2015   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00297479 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Group Therapy for Nicotine Dependence: Mindfulness and Smoking
Group Therapy for Nicotine Dependence

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Smoking
  • Tobacco Use Cessation
  • 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
  • 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
  • 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
  • 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.
    Interventions:
    • Behavioral: MBAT Group Therapy
    • Drug: Nicotine
  • 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
    Interventions:
    • Drug: Nicotine
    • Behavioral: Group Therapy
  • 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
    Interventions:
    • Drug: Nicotine
    • Behavioral: Individual Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: David Wetter, Ph.D. 713-745-2682
United States
 
NCT00297479
2004-0988, R01DA018875
Yes
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Institute on Drug Abuse (NIDA)
Principal Investigator: David W Wetter, Ph.D. UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP