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Completed

NCT Number: NCT00581464

Healthier Hearts and Brains in Treating Smoking: The HABITS Study

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.

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Key information

Conditions

Smoking Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Cessation Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Standard Behavioral Therapy

Behavioral

Standard therapy to help participants with smoking cessation.

Mindfulness Based Addiction Therapy

Behavioral

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.

Primary outcomes

  1. Smoking Cessation

    Time frame: week 2 and 6 month follow-up

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Acronym: HABITS

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 27, 2007
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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