Mindfulness Training for Smoking Cessation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Judson Brewer, Yale University
ClinicalTrials.gov Identifier:
NCT01144689
First received: June 14, 2010
Last updated: July 9, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Between group differences in perceived stress [ Time Frame: 6, 12 and 18 weeks after treatment initiation ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144689

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

Additional Information:
Publications:
Responsible Party: Judson Brewer, Assistant Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT01144689     History of Changes
Other Study ID Numbers: 0808004113
Study First Received: June 14, 2010
Last Updated: July 9, 2013
Health Authority: United States: Federal Government

Keywords provided by Yale University:
mindfulness
smoking
stress

Additional relevant MeSH terms:
Tobacco Use Disorder
Smoking
Substance-Related Disorders
Mental Disorders
Habits

ClinicalTrials.gov processed this record on July 24, 2014