Clinical trial NCT00581464: Healthier Hearts and Brains in Treating Smoking: The HABITS Study
Official title: Healthier Hearts and Brains in Treating Smoking: The HABITS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking cessation
Tobacco dependence
Mindfulness
fMRI
Craving
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2007-12-27
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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).

Primary outcomes:
measure: Smoking Cessation
timeFrame: week 2 and 6 month follow-up
Secondary outcomes:
measure: Exhaled CO readings
timeFrame: baseline, weeks 2-4, post class follow-up, long term follow-up
measure: Saliva Test
timeFrame: baseline
measure: Functional Magnetic Resonance Imaging
timeFrame: baseline & follow-up
measure: Urine Pregnancy Test
timeFrame: baseline & follow-up
measure: Nicotine Replacement Therapy
timeFrame: Week 1
measure: Self Reported Measures
timeFrame: baseline, post class follow-up & long term follow-up
measure: Standard Cognitive Therapy
timeFrame: weeks 1-4
measure: Mindfulness Based Cognitive Therapy
timeFrame: weeks 1-4
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Hilary Tindle, MD
role: PRINCIPAL_INVESTIGATOR
References: