Healthier Hearts and Brains in Treating Smoking: The HABITS Study

Study Overview
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Brief Summary
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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.

Official Title
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Healthier Hearts and Brains in Treating Smoking: The HABITS Study

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Standard Behavioral Therapy
* Behavioral: Mindfulness Based Addiction Therapy


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Behavioral: Standard Behavioral Therapy<br>* Standard therapy to help participants with smoking cessation.<br>|
| Active Comparator: 2<br> | Behavioral: Mindfulness Based Addiction Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Cessation |  | week 2 and 6 month follow-up | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Tobacco dependence, Mindfulness, fMRI, Craving