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Mindfulness Training for Smoking Cessation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01144689
First Posted: June 15, 2010
Last Update Posted: July 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yale University
  Purpose
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.

Condition Intervention
Cigarette Smoking Tobacco Smoking Nicotine Dependence Smoking Cessation Behavioral: Mindfulness Training Behavioral: Smoking Cessation Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing Mindfulness Training as a Mechanistic Probe for Stress-Induced Brain Activation and Relapse Prevention for Tobacco Addiction

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Between group differences in continuous abstinence [ Time Frame: during treatment and 6, 12 and 18 weeks after treatment initiation ]

Secondary Outcome Measures:
  • Between group differences in perceived stress [ Time Frame: 6, 12 and 18 weeks after treatment initiation ]

Enrollment: 42
Study Start Date: February 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness Training Behavioral: Mindfulness Training
8 sessions of behavioral treatment for smoking cessation
Active Comparator: Smoking Cessation Therapy Behavioral: Smoking Cessation Therapy
8 sessions of behavioral treatment for smoking cessation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between the ages of 18 and 60
  2. Smoking 10 or more cigarettes per day
  3. Fewer than 3 months of smoking abstinence in the past year
  4. Motivated to stop smoking

Exclusion Criteria:

  1. 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.
  2. Use of another investigational drug within 30 days
  3. Any serious or unstable disease within 6 months
  4. Meets criteria for substance dependence within the past year
  5. Left handed (will be excluded from fMRI only)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144689


Locations
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
  More Information

Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01144689     History of Changes
Other Study ID Numbers: 0808004113
First Submitted: June 14, 2010
First Posted: June 15, 2010
Last Update Posted: July 7, 2016
Last Verified: July 2016

Keywords provided by Yale University:
mindfulness
smoking
stress

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders