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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00581464
First received: December 20, 2007
Last updated: April 25, 2017
Last verified: April 2017
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Healthier Hearts and Brains in Treating Smoking: The HABITS Study

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Smoking Cessation [ Time Frame: week 2 and 6 month follow-up ]

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

Enrollment: 79
Study Start Date: November 2009
Study Completion Date: December 2010
Primary Completion Date: December 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   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581464

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

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00581464     History of Changes
Other Study ID Numbers: PRO08030007
Study First Received: December 20, 2007
Last Updated: April 25, 2017

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

ClinicalTrials.gov processed this record on August 18, 2017