Healthier Hearts and Brains in Treating Smoking: The HABITS Study

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Behavioral: Mindfulness Based Addiction Therapy; Behavioral: Standard Behavioral Therapy

• Registration Number: NCT00581464
• Lead Sponsor: University of Pittsburgh

Brief Summary

80 nicotine dependent adults ages 18-65 who desire to quit smoking will be screened and, if eligible, enrolled and randomized to one of two four-week treatments for smoking cessation. The treatments are standard behavioral therapy and Mindfulness Based Addiction Therapy (MBAT), which is standard therapy plus mindfulness. Standard therapy and MBAT incorporate elements of widely-used tools for smoking cessation including managing craving and strong emotions, problem solving, tips on healthy eating and keeping active, and exercises based on cognitive and behavioral therapy. MBAT uniquely incorporates mindfulness practice (a relaxation therapy) into standard therapy. Participants complete questionnaires and undergo an fMRI scan at baseline and at the end of therapy (after they complete the 4 weeks of standard therapy or MBAT). During each scan, participants will complete a validated smoking-related cue paradigm and a validated affect labeling paradigm.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2007-12-27
• Study Start: 2009-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• Participants will be considered eligible for enrollment if they are between 18-65 years old, smoke at least ½ pack cigarettes per day, desire to quit smoking (self-reported 75+ out of a possible 100), and have no contraindications for varenicline medication therapy or fMRI scanning (such as body weight over 250 lbs, intravascular metal devices including stents, or claustrophobia).

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Exclusion Criteria

• Participants will not be considered eligible for enrollment if they are not between 18-65 years old, smoke less than ½ pack cigarettes per day, do not desire to quit smoking (self-reported -75 out of a possible 100), or have contraindications for varenicline medication therapy or fMRI scanning (such as body weight over 250 lbs, intravascular metal devices including stents, or claustrophobia).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Mindfulness Based Addiction Therapy	-
1	Standard Behavioral Therapy	-

Primary Outcome Measures

Name	Time	Method
Smoking Cessation	week 2 and 6 month follow-up

Secondary Outcome Measures

Name	Time	Method
Urine Pregnancy Test	baseline & follow-up
Exhaled CO readings	baseline, weeks 2-4, post class follow-up, long term follow-up
Saliva Test	baseline
Functional Magnetic Resonance Imaging	baseline & follow-up
Nicotine Replacement Therapy	Week 1
Self Reported Measures	baseline, post class follow-up & long term follow-up
Mindfulness Based Cognitive Therapy	weeks 1-4
Standard Cognitive Therapy	weeks 1-4

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States