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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

December 20, 2007
January 21, 2010
November 2009
June 2010   (final data collection date for primary outcome measure)
Smoking Cessation [ Time Frame: week 2 and 6 month follow-up ] [ Designated as safety issue: No ]
Smoking Cessation [ Time Frame: pre-session-week8 and 6 month follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00581464 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Exhaled CO readings [ Time Frame: baseline, sessions 5,6,7, & 8 ] [ Designated as safety issue: No ]
  • Saliva Test [ Time Frame: baseline, sessions 5 & 8 ] [ Designated as safety issue: No ]
  • Functional Magnetic Resonance Imaging [ Time Frame: sessions 1, 5, & 8 ] [ Designated as safety issue: No ]
  • Urine Pregnancy Test [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Chantix medication [ Time Frame: Sessions 4-16 ] [ Designated as safety issue: No ]
  • DNA testing [ Time Frame: baseline & session 8 ] [ Designated as safety issue: No ]
  • Self Reported Measures [ Time Frame: baseline, sessions 8 & 6-month follow up ] [ Designated as safety issue: No ]
  • Standard Cognitive Therapy [ Time Frame: baseline - session 8 ] [ Designated as safety issue: No ]
  • Mindfulness Based Cognitive Therapy [ Time Frame: baseline - session 8 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Healthier Hearts and Brains in Treating Smoking: The HABITS Study
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Smoking
  • Behavioral: Standard Behavioral Therapy
    Standard therapy to help participants with smoking cessation.
  • 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.
  • Active Comparator: 1
    Intervention: Behavioral: Standard Behavioral Therapy
  • Active Comparator: 2
    Intervention: Behavioral: Mindfulness Based Addiction Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
June 2011
June 2010   (final data collection date for primary outcome measure)

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).
Both
18 Years to 65 Years
Yes
Contact: Hilary Tindle, MD 412 246 6929 tindleha@upmc.edu
United States
 
NCT00581464
PRO07100068, PRO07100068
Yes
Dr. Hilary Tindle, University of Pittsburgh Department of Internal Medicine
University of Pittsburgh
Not Provided
Principal Investigator: Hilary Tindle, MD University of Pittsburgh
University of Pittsburgh
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP