Behavioral Therapy for Reduction in Smoking Craving

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-05-31

Brief Summary

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The objective of this pilot research is to investigate the effects of two behavioral smoking cessation programs on aspects of cue-induced cigarette craving, and to further investigate the neural bases of such effects.

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Detailed Description

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The objective of this pilot research is to investigate the effects of two behavioral smoking cessation programs on aspects of cue-induced cigarette craving, and to further investigate the neural bases of such effects. The specific objectives of the study include 1) to investigate the effects of behavioral therapy on cue induced craving using a cognitive task and a fMRI paradigm 2) to pilot test questionnaires and study procedures, and 3) to gather preliminary estimates of the effect size of the novel behavioral therapy for smoking cessation in order to inform the design of a larger trial. A secondary goal of this research is 1) to determine the impact of two cognitive coping techniques on attentional bias to smoking related cues as measured by behavioral responses and patterns of neural activation and 2) to determine the impact of two cognitive coping techniques on cue-induced cigarette craving as measured by self-report and patterns of neural activation. Daily smokers desiring to quit smoking were randomized to one of two behavioral smoking cessation programs: (1) standard cognitive behavioral therapy or (2) mindfulness-based cognitive therapy. Participants completed questionnaires and a brief computer-based cognitive testing paradigm. Participants also underwent a fMRI scan at quit day (week 5). A randomly assigned subset of the participants (n= 18), underwent two additional scans at baseline (week 1) and end-of-therapy (week 8). The study has thus used self-report measures, cognitive testing (Stroop task), and fMRI (functional magnetic resonance imaging) assessments.

Conditions

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Smoking Cessation Tobacco Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

standard cognitive behavioral therapy

Intervention Type BEHAVIORAL

Standard therapy to help participants with smoking cessation.

2

Group Type ACTIVE_COMPARATOR

Mindfulness Based Cognitive Therapy

Intervention Type BEHAVIORAL

A novel mind body therapy that extends basic CT principles to include the practice of mindfulness, which fosters a dispassionate approach to the experience of craving.

Interventions

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standard cognitive behavioral therapy

Standard therapy to help participants with smoking cessation.

Intervention Type BEHAVIORAL

Mindfulness Based Cognitive Therapy

A novel mind body therapy that extends basic CT principles to include the practice of mindfulness, which fosters a dispassionate approach to the experience of craving.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Currently be cigarette smokers who desire to quit in the next 30 days (preparation phase).
* Subjects must smoke at least 10 cigarettes per day
* Must be at least 18 years old
* English speaking
* Able to read, understand, and complete a written questionnaire
* Must be willing to attend 8 sessions of behavioral therapy and perform daily home practice
* Must not currently be using pharmacologic therapy to quit
* Must also be willing to abstain from pharmacologic therapy for the duration of the study, which is 8 weeks from the time of enrollment.
* Only strongly right-handed subjects will be included

Exclusion Criteria

* Pregnant women
* Have metal permanently in or on the body (aneurysm clips, permanent piercings, permanent dental work)
* Weigh over 300 pounds
* Known problem of claustrophobia

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes