Healthier Hearts and Brains in Treating Smoking: The HABITS Study

NCT00581464 | Completed DMC

• 1 other identifier: PRO08030007
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

Smoking cessation; Tobacco dependence; Mindfulness; fMRI; Craving

Outcome Measures

Primary Outcomes (1)

• Smoking Cessation

  week 2 and 6 month follow-up

Secondary Outcomes (8)

• 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

• Urine Pregnancy Test

  baseline & follow-up

• Nicotine Replacement Therapy

  Week 1

Study Arms (2)

1

ACTIVE COMPARATOR

Behavioral: Standard Behavioral Therapy

2

ACTIVE COMPARATOR

Behavioral: Mindfulness Based Addiction Therapy

Interventions

Standard Behavioral Therapy BEHAVIORAL

Standard therapy to help participants with smoking cessation.

1

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.

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Hilary Tindle, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 27, 2007
• Study Start: November 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

US (1)