NCT01144689
Completed
Not Applicable
Assessing Mindfulness Training as a Mechanistic Probe for Stress-Induced Brain Activation and Relapse Prevention for Tobacco Addiction
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Between group differences in continuous abstinence
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Between group differences in continuous abstinence
Time Frame: during treatment and 6, 12 and 18 weeks after treatment initiation
Secondary Outcomes
- Between group differences in perceived stress(6, 12 and 18 weeks after treatment initiation)
Investigators
Study Sites (1)
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