Mindfulness Training for Smoking Cessation

NCT01144689 | Completed DMC

• 1 other identifier: 0808004113
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cigarette Smoking; Tobacco Smoking; Nicotine Dependence; Smoking Cessation

Keywords

mindfulness; smoking; stress

Outcome Measures

Primary Outcomes (1)

• Between group differences in continuous abstinence

  during treatment and 6, 12 and 18 weeks after treatment initiation

Secondary Outcomes (1)

• Between group differences in perceived stress

  6, 12 and 18 weeks after treatment initiation

Study Arms (2)

Mindfulness Training

EXPERIMENTAL

Behavioral: Mindfulness Training

Smoking Cessation Therapy

ACTIVE COMPARATOR

Behavioral: Smoking Cessation Therapy

Interventions

Mindfulness Training BEHAVIORAL

8 sessions of behavioral treatment for smoking cessation

Mindfulness Training

Smoking Cessation Therapy BEHAVIORAL

8 sessions of behavioral treatment for smoking cessation

Smoking Cessation Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

Related Publications (3)

• 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. 2011 Dec 1;119(1-2):72-80. doi: 10.1016/j.drugalcdep.2011.05.027. Epub 2011 Jul 1.

  PMID: 21723049 RESULT

• 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.2012.11.015. Epub 2012 Dec 21.

  PMID: 23265088 RESULT

• Kober H, Brewer JA, Height KL, Sinha R. Neural stress reactivity relates to smoking outcomes and differentiates between mindfulness and cognitive-behavioral treatments. Neuroimage. 2017 May 1;151:4-13. doi: 10.1016/j.neuroimage.2016.09.042. Epub 2016 Sep 28.

  PMID: 27693614 DERIVED

MeSH Terms

Conditions

Cigarette Smoking; Tobacco Smoking; Tobacco Use Disorder; Smoking Cessation; Smoking

Condition Hierarchy (Ancestors)

Behavior; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 15, 2010
• Study Start: February 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: July 7, 2016

Record last verified: 2016-07

Locations

US (1)