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Clinical Trials/NCT01144689
NCT01144689
Completed
Not Applicable

Assessing Mindfulness Training as a Mechanistic Probe for Stress-Induced Brain Activation and Relapse Prevention for Tobacco Addiction

Yale University1 site in 1 country42 target enrollmentStarted: February 2009Last updated:

Overview

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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