Mindfulness Training for Smoking Cessation

NCT ID: NCT01144689

Last Updated: 2016-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Cigarette Smoking Tobacco Smoking Nicotine Dependence Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness Training

Group Type EXPERIMENTAL

Mindfulness Training

Intervention Type BEHAVIORAL

8 sessions of behavioral treatment for smoking cessation

Smoking Cessation Therapy

Group Type ACTIVE_COMPARATOR

Smoking Cessation Therapy

Intervention Type BEHAVIORAL

8 sessions of behavioral treatment for smoking cessation

Interventions

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Mindfulness Training

8 sessions of behavioral treatment for smoking cessation

Intervention Type BEHAVIORAL

Smoking Cessation Therapy

8 sessions of behavioral treatment for smoking cessation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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VA Connecticut Healthcare System

West Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21723049 (View on PubMed)

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.

Reference Type RESULT
PMID: 23265088 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27693614 (View on PubMed)

Other Identifiers

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0808004113

Identifier Type: -

Identifier Source: org_study_id

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