Healthier Hearts and Brains in Treating Smoking: The HABITS Study (HABITS)
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ClinicalTrials.gov Identifier: NCT00581464 |
Recruitment Status :
Completed
First Posted : December 27, 2007
Last Update Posted : April 27, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking | Behavioral: Standard Behavioral Therapy Behavioral: Mindfulness Based Addiction Therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 79 participants |
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 |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
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. |
- Smoking Cessation [ Time Frame: week 2 and 6 month follow-up ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581464
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Hilary Tindle, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00581464 |
Other Study ID Numbers: |
PRO08030007 |
First Posted: | December 27, 2007 Key Record Dates |
Last Update Posted: | April 27, 2017 |
Last Verified: | April 2017 |
Smoking cessation Tobacco dependence Mindfulness fMRI Craving |