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Healthier Hearts and Brains in Treating Smoking: The HABITS Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00581464
First received: December 20, 2007
Last updated: January 21, 2010
Last verified: January 2010
History of Changes
  Purpose

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 Intervention
Smoking
 Behavioral: Standard Behavioral Therapy
Behavioral: Mindfulness Based Addiction Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Healthier Hearts and Brains in Treating Smoking: The HABITS Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Smoking Cessation [ Time Frame: week 2 and 6 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exhaled CO readings [ Time Frame: baseline, weeks 2-4, post class follow-up, long term follow-up ] [ Designated as safety issue: No ]
  • Saliva Test [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Functional Magnetic Resonance Imaging [ Time Frame: baseline & follow-up ] [ Designated as safety issue: No ]
  • Urine Pregnancy Test [ Time Frame: baseline & follow-up ] [ Designated as safety issue: No ]
  • Nicotine Replacement Therapy [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
  • Self Reported Measures [ Time Frame: baseline, post class follow-up & long term follow-up ] [ Designated as safety issue: No ]
  • Standard Cognitive Therapy [ Time Frame: weeks 1-4 ] [ Designated as safety issue: No ]
  • Mindfulness Based Cognitive Therapy [ Time Frame: weeks 1-4 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581464

Contacts
Contact: Hilary Tindle, MD 412 246 6929 tindleha@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Hilary Tindle, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Dr. Hilary Tindle, University of Pittsburgh Department of Internal Medicine
ClinicalTrials.gov Identifier: NCT00581464     History of Changes
Other Study ID Numbers: PRO07100068, PRO07100068
Study First Received: December 20, 2007
Last Updated: January 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Smoking cessation
Tobacco dependence
Mindfulness
fMRI
Craving

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 16, 2013