search
Back to results

Group Therapy for Nicotine Dependence: Mindfulness and Smoking

Primary Purpose

Smoking, Tobacco Use Cessation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MBAT Group Therapy
Nicotine
Group Therapy
Individual Therapy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking focused on measuring Tobacco Cessation, Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Mindfulness-Based Treatment Group (MBAT)

Standard Care Group

Usual Care Group

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Number of Participants With Smoking Abstinence
Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.
Smoking Abstinence
Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
Smoking Abstinence
Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach

Secondary Outcome Measures

Full Information

First Posted
February 24, 2006
Last Updated
June 3, 2020
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00297479
Brief Title
Group Therapy for Nicotine Dependence: Mindfulness and Smoking
Official Title
Group Therapy for Nicotine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Tobacco Use Cessation
Keywords
Tobacco Cessation, Smoking Cessation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
650 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Treatment Group (MBAT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Usual Care Group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
MBAT Group Therapy
Other Intervention Name(s)
therapy, counseling
Intervention Description
In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence
Intervention Type
Drug
Intervention Name(s)
Nicotine
Other Intervention Name(s)
nicotine patch therapy
Intervention Description
6 weeks of nicotine patch therapy
Intervention Type
Behavioral
Intervention Name(s)
Group Therapy
Other Intervention Name(s)
counseling
Intervention Description
In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
Intervention Type
Behavioral
Intervention Name(s)
Individual Therapy
Other Intervention Name(s)
counseling
Intervention Description
In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
Primary Outcome Measure Information:
Title
Number of Participants With Smoking Abstinence
Description
Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.
Time Frame
4 weeks post quit day (one week following the end of treatment)
Title
Smoking Abstinence
Description
Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
Time Frame
26 weeks post quit day
Title
Smoking Abstinence
Description
Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
Time Frame
4 weeks post quit day (one week following the end of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W Wetter, Ph.D.
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35420700
Citation
Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
Results Reference
derived
PubMed Identifier
28191263
Citation
Vidrine JI, Businelle MS, Reitzel LR, Cao Y, Cinciripini PM, Marcus MT, Li Y, Wetter DW. Coping Mediates the Association of Mindfulness with Psychological Stress, Affect, and Depression Among Smokers Preparing to Quit. Mindfulness (N Y). 2015 Jun;6(3):433-443. doi: 10.1007/s12671-014-0276-4. Epub 2014 Jan 18.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Group Therapy for Nicotine Dependence: Mindfulness and Smoking

We'll reach out to this number within 24 hrs