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Completed

NCT Number: NCT00297479

Group Therapy for Nicotine Dependence: Mindfulness and Smoking

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBAT Group Therapy

Behavioral

In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence

Other names: therapy, counseling

nicotine

Drug

6 weeks of nicotine patch therapy

Other names: nicotine patch therapy

Group Therapy

Behavioral

In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline

Other names: counseling

Individual therapy

Behavioral

In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline

Other names: counseling

Primary outcomes

  1. 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.

  2. Smoking Abstinence

    Time frame: 26 weeks post quit day

    Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach

  3. 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

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Group Therapy for Nicotine Dependence

Important dates

Study start
2005
Primary completion
2016
Study completion
2016
First posted
Feb 28, 2006
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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