Smoking Cessation Behavioral Treatment Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of two behavioral interventions on smoking behavior - Mindfulness-Oriented Recovery Enhancement (MORE) and Cognitive Behavioral Therapy (CBT). MORE is a behavioral therapy that integrates mindfulness training to modify reward processes. CBT is a therapy designed to help individuals understand how their thoughts and feelings influence their behaviors.

Official Title
-----------------
Neural Mechanisms Mediating Appetitive Regulation and Smoking in Nicotine Addiction

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)
* Behavioral: Cognitive Behavioral Therapy (CBT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and up English fluency as demonstrated in providing informed consent and the ability to independently follow directions in completing assigned assessments and tasks Functional vision (with corrective lenses as needed) to complete assigned assessments and tasks Current nicotine dependent smoker with a minimum smoking history of 2 years Interest in quitting smoking Exclusion Criteria: Use of psychotropic (e.g. antiepileptic) medications in the past month Positive urine drug screen Presence of an untreated medical illness Current or past psychosis History of major neurological illness or head injury resulting in loss of consciousness And contraindication to MRI, including claustrophobia Among females, positive urine pregnancy test Inability or unwillingness of subject to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MORE<br> | Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)<br>* MORE is a behavioral therapy that integrates mindfulness training to modify reward processes.<br>|
| Active Comparator: CBT<br> | Behavioral: Cognitive Behavioral Therapy (CBT)<br>* CBT is a therapy designed to help individuals understand how their thoughts and feelings influence their behaviors.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarette Smoking | Biochemical smoking assessment (breath carbon monoxide) at each study visit. | 7 weeks | 
| Magnitude of change in fMRI brain response to images | Measure the effects of MORE on fMRI BOLD response to images (change from baseline to end of study) while participants undergo functional magnetic resonance imaging | 7 weeks | 
| Magnitude of change in fMRI brain connectivity | Measure the effects of MORE on resting-state functional connectivity (change from baseline to end of study) while participants undergo functional magnetic resonance imaging. | 7 weeks |