Mindfulness Training for Smoking Cessation
This study is ongoing, but not recruiting participants.
Sponsor:
Yale University
Information provided by (Responsible Party):
Judson Brewer, Yale University
ClinicalTrials.gov Identifier:
NCT01144689
First received: June 14, 2010
Last updated: February 27, 2012
Last verified: February 2012
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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 ]
- Brain activation of abstainers and smokers during stressful versus neutral imagery [ Time Frame: 6 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 ]
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2009 |
| Estimated Primary Completion Date: | December 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:
- 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)
Contacts and Locations 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: | February 27, 2012 |
| 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 May 16, 2013