Mindfulness Training for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144689
• Other study ID #: 0808004113
• Status: Completed
• Phase: N/A
• First received: June 14, 2010
• Last updated: July 5, 2016
• Start date: February 2009
• Est. completion date: February 2013

Study information

• Verified date: July 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cigarette Smoking
• Nicotine Dependence
• Smoking Cessation
• Tobacco Smoking
• Tobacco Use Disorder

Intervention

Behavioral:
• Mindfulness Training
8 sessions of behavioral treatment for smoking cessation
• Smoking Cessation Therapy
8 sessions of behavioral treatment for smoking cessation

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Brewer JA, Mallik S, Babuscio TA, Nich C, Johnson HE, Deleone CM, Minnix-Cotton CA, Byrne SA, Kober H, Weinstein AJ, Carroll KM, Rounsaville BJ. Mindfulness training for smoking cessation: results from a randomized controlled trial. Drug Alcohol Depend. 2 — View Citation

Elwafi HM, Witkiewitz K, Mallik S, Thornhill TA 4th, Brewer JA. Mindfulness training for smoking cessation: moderation of the relationship between craving and cigarette use. Drug Alcohol Depend. 2013 Jun 1;130(1-3):222-9. doi: 10.1016/j.drugalcdep.2012.11 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Between group differences in continuous abstinence		during treatment and 6, 12 and 18 weeks after treatment initiation	No
Secondary	Between group differences in perceived stress		6, 12 and 18 weeks after treatment initiation	No