Mindfulness Training for Smoking Cessation

July 5, 2016 updated by: Yale University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Between group differences in continuous abstinence
Time Frame: during treatment and 6, 12 and 18 weeks after treatment initiation
during treatment and 6, 12 and 18 weeks after treatment initiation

Secondary Outcome Measures

Outcome Measure
Time Frame
Between group differences in perceived stress
Time Frame: 6, 12 and 18 weeks after treatment initiation
6, 12 and 18 weeks after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

June 14, 2010

First Submitted That Met QC Criteria

June 14, 2010

First Posted (Estimate)

June 15, 2010

Study Record Updates

Last Update Posted (Estimate)

July 7, 2016

Last Update Submitted That Met QC Criteria

July 5, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0808004113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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