Healthier Hearts and Brains in Treating Smoking: The HABITS Study

Smoking Clinical Trial

— HABITS  

Official title:

Healthier Hearts and Brains in Treating Smoking: The HABITS Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581464
• Other study ID #: PRO08030007
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: April 25, 2017
• Start date: November 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Standard Behavioral Therapy
Standard therapy to help participants with smoking cessation.
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Cessation		week 2 and 6 month follow-up
Secondary	Exhaled CO readings		baseline, weeks 2-4, post class follow-up, long term follow-up
Secondary	Saliva Test		baseline
Secondary	Functional Magnetic Resonance Imaging		baseline & follow-up
Secondary	Urine Pregnancy Test		baseline & follow-up
Secondary	Nicotine Replacement Therapy		Week 1
Secondary	Self Reported Measures		baseline, post class follow-up & long term follow-up
Secondary	Standard Cognitive Therapy		weeks 1-4
Secondary	Mindfulness Based Cognitive Therapy		weeks 1-4