Group Therapy for Nicotine Dependence: Mindfulness and Smoking

Smoking Clinical Trial

Official title:

Group Therapy for Nicotine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297479
• Other study ID #: 2004-0988
• Secondary ID: R01DA018875NCI-2
• Status: Completed
• Phase: N/A
• Start date: April 2005
• Est. completion date: September 2016

Study information

• Verified date: June 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking
• Tobacco Use Cessation
• Tobacco Use Disorder

Intervention

Behavioral:
• MBAT Group Therapy
In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence

Drug:
• Nicotine
6 weeks of 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
• Individual Therapy
In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Smoking Abstinence	Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.	4 weeks post quit day (one week following the end of treatment)
Primary	Smoking Abstinence	Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach	26 weeks post quit day
Primary	Smoking Abstinence	Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach	4 weeks post quit day (one week following the end of treatment)

External Links

•   University of Texas MD Anderson Cancer Center Website