Healthier Hearts and Brains in Treating Smoking: The HABITS Study (HABITS)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Smoking	Behavioral: Standard Behavioral Therapy; Behavioral: Mindfulness Based Addiction Therapy	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	79 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Healthier Hearts and Brains in Treating Smoking: The HABITS Study
Study Start Date :	November 2009
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	December 2010

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: 1	Behavioral: Standard Behavioral Therapy; Standard therapy to help participants with smoking cessation.
Active Comparator: 2	Behavioral: Mindfulness Based Addiction Therapy; A novel mind body therapy that extends basic behavioral therapy principles to include the practice of mindfulness, which fosters a dispassionate approach to the experience of craving.

Outcome Measures

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Primary Outcome Measures :

1. Smoking Cessation [ Time Frame: week 2 and 6 month follow-up ]

Secondary Outcome Measures :

1. Exhaled CO readings [ Time Frame: baseline, weeks 2-4, post class follow-up, long term follow-up ]
2. Saliva Test [ Time Frame: baseline ]
3. Functional Magnetic Resonance Imaging [ Time Frame: baseline & follow-up ]
4. Urine Pregnancy Test [ Time Frame: baseline & follow-up ]
5. Nicotine Replacement Therapy [ Time Frame: Week 1 ]
6. Self Reported Measures [ Time Frame: baseline, post class follow-up & long term follow-up ]
7. Standard Cognitive Therapy [ Time Frame: weeks 1-4 ]
8. Mindfulness Based Cognitive Therapy [ Time Frame: weeks 1-4 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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).

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).

Contacts and Locations

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Locations

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:	Hilary Tindle, MD	University of Pittsburgh

More Information

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Responsible Party:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00581464 History of Changes
Other Study ID Numbers:	PRO08030007
First Posted:	December 27, 2007
Last Update Posted:	April 27, 2017
Last Verified:	April 2017

Keywords provided by University of Pittsburgh:

Smoking cessation; Tobacco dependence; Mindfulness; fMRI; Craving