Back to resultsMindfulness Training for Smoking Cessation
Primary Purpose
Cigarette Smoking, Tobacco Smoking, Nicotine Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Training
Smoking Cessation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cigarette Smoking focused on measuring mindfulness, smoking, stress
Eligibility Criteria
Inclusion Criteria:
- Between the ages of 18 and 60
- Smoking 10 or more cigarettes per day
- Fewer than 3 months of smoking abstinence in the past year
- Motivated to stop smoking
Exclusion Criteria:
- Current use of psychoactive medications that have not been at a stable dose for the past six months, are used as mood stabilizers, or are used as smoking cessation treatments. Individuals who are on psychoactive medications that are stable, not mood stabilizers, and not used for smoking cessations are excluded from fMRI sessions but not smoking cessation treatment.
- Use of another investigational drug within 30 days
- Any serious or unstable disease within 6 months
- Meets criteria for substance dependence within the past year
- Left handed (will be excluded from fMRI only)
Sites / Locations
- VA Connecticut Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness Training
Smoking Cessation Therapy
Arm Description
Outcomes
Primary Outcome Measures
Between group differences in continuous abstinence
Secondary Outcome Measures
Between group differences in perceived stress
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01144689
Brief Title
Mindfulness Training for Smoking Cessation
Official Title
Assessing Mindfulness Training as a Mechanistic Probe for Stress-Induced Brain Activation and Relapse Prevention for Tobacco Addiction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the effects of mindfulness training (MT) compared to standard Smoking Cessation Therapy (SCT) on smoking cessation and stress provocation in individuals trying to quit smoking.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cigarette Smoking, Tobacco Smoking, Nicotine Dependence, Smoking Cessation
Keywords
mindfulness, smoking, stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Training
Arm Type
Experimental
Arm Title
Smoking Cessation Therapy
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Training
Intervention Description
8 sessions of behavioral treatment for smoking cessation
Intervention Type
Behavioral
Intervention Name(s)
Smoking Cessation Therapy
Intervention Description
8 sessions of behavioral treatment for smoking cessation
Primary Outcome Measure Information:
Title
Between group differences in continuous abstinence
Time Frame
during treatment and 6, 12 and 18 weeks after treatment initiation
Secondary Outcome Measure Information:
Title
Between group differences in perceived stress
Time Frame
6, 12 and 18 weeks after treatment initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between the ages of 18 and 60
Smoking 10 or more cigarettes per day
Fewer than 3 months of smoking abstinence in the past year
Motivated to stop smoking
Exclusion Criteria:
Current use of psychoactive medications that have not been at a stable dose for the past six months, are used as mood stabilizers, or are used as smoking cessation treatments. Individuals who are on psychoactive medications that are stable, not mood stabilizers, and not used for smoking cessations are excluded from fMRI sessions but not smoking cessation treatment.
Use of another investigational drug within 30 days
Any serious or unstable disease within 6 months
Meets criteria for substance dependence within the past year
Left handed (will be excluded from fMRI only)
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21723049
Citation
Brewer JA, Mallik S, Babuscio TA, Nich C, Johnson HE, Deleone CM, Minnix-Cotton CA, Byrne SA, Kober H, Weinstein AJ, Carroll KM, Rounsaville BJ. Mindfulness training for smoking cessation: results from a randomized controlled trial. Drug Alcohol Depend. 2011 Dec 1;119(1-2):72-80. doi: 10.1016/j.drugalcdep.2011.05.027. Epub 2011 Jul 1.
Results Reference
result
PubMed Identifier
23265088
Citation
Elwafi HM, Witkiewitz K, Mallik S, Thornhill TA 4th, Brewer JA. Mindfulness training for smoking cessation: moderation of the relationship between craving and cigarette use. Drug Alcohol Depend. 2013 Jun 1;130(1-3):222-9. doi: 10.1016/j.drugalcdep.2012.11.015. Epub 2012 Dec 21.
Results Reference
result
PubMed Identifier
27693614
Citation
Kober H, Brewer JA, Height KL, Sinha R. Neural stress reactivity relates to smoking outcomes and differentiates between mindfulness and cognitive-behavioral treatments. Neuroimage. 2017 May 1;151:4-13. doi: 10.1016/j.neuroimage.2016.09.042. Epub 2016 Sep 28.
Results Reference
derived
Learn more about this trial
Mindfulness Training for Smoking Cessation
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