Group Therapy for Nicotine Dependence: Mindfulness and Smoking
3 other identifiers
interventional
650
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 24, 2006
CompletedFirst Posted
Study publicly available on registry
February 28, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
June 16, 2020
CompletedJune 16, 2020
June 1, 2020
11.4 years
February 24, 2006
February 3, 2020
June 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
Smoking Abstinence
Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
26 weeks post quit day
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)
Study Arms (3)
Mindfulness-Based Treatment Group (MBAT)
EXPERIMENTALMBAT 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
ACTIVE COMPARATORStandard 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 Group
ACTIVE COMPARATORUsual 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
In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence
6 weeks of nicotine patch therapy
In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (2)
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.
PMID: 35420700DERIVEDVidrine 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.
PMID: 28191263DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sharon Giordano, MD/Chair, Health Svcs Research-Clinical
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
David W Wetter, Ph.D.
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2006
First Posted
February 28, 2006
Study Start
April 1, 2005
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
June 16, 2020
Results First Posted
June 16, 2020
Record last verified: 2020-06