Behavioral Therapy for Reduction in Smoking Craving

Study Overview
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Brief Summary
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The objective of this pilot research is to investigate the effects of two behavioral smoking cessation programs on aspects of cue-induced cigarette craving, and to further investigate the neural bases of such effects.

Detailed Description
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The objective of this pilot research is to investigate the effects of two behavioral smoking cessation programs on aspects of cue-induced cigarette craving, and to further investigate the neural bases of such effects. The specific objectives of the study include 1) to investigate the effects of behavioral therapy on cue induced craving using a cognitive task and a fMRI paradigm 2) to pilot test questionnaires and study procedures, and 3) to gather preliminary estimates of the effect size of the novel behavioral therapy for smoking cessation in order to inform the design of a larger trial. A secondary goal of this research is 1) to determine the impact of two cognitive coping techniques on attentional bias to smoking related cues as measured by behavioral responses and patterns of neural activation and 2) to determine the impact of two cognitive coping techniques on cue-induced cigarette craving as measured by self-report and patterns of neural activation. Daily smokers desiring to quit smoking were randomized to one of two behavioral smoking cessation programs: (1) standard cognitive behavioral therapy or (2) mindfulness-based cognitive therapy. Participants completed questionnaires and a brief computer-based cognitive testing paradigm. Participants also underwent a fMRI scan at quit day (week 5). A randomly assigned subset of the participants (n= 18), underwent two additional scans at baseline (week 1) and end-of-therapy (week 8). The study has thus used self-report measures, cognitive testing (Stroop task), and fMRI (functional magnetic resonance imaging) assessments.

Official Title
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Behavioral Therapy for Reduction in Smoking Craving

Conditions
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Smoking Cessation, Tobacco Dependence

Intervention / Treatment
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* Behavioral: standard cognitive behavioral therapy
* Behavioral: Mindfulness Based Cognitive Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently be cigarette smokers who desire to quit in the next 30 days (preparation phase). Subjects must smoke at least 10 cigarettes per day Must be at least 18 years old English speaking Able to read, understand, and complete a written questionnaire Must be willing to attend 8 sessions of behavioral therapy and perform daily home practice Must not currently be using pharmacologic therapy to quit Must also be willing to abstain from pharmacologic therapy for the duration of the study, which is 8 weeks from the time of enrollment. Only strongly right-handed subjects will be included Exclusion Criteria: Pregnant women Have metal permanently in or on the body (aneurysm clips, permanent piercings, permanent dental work) Weigh over 300 pounds Known problem of 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 cognitive behavioral therapy<br>* Standard therapy to help participants with smoking cessation.<br>|
| Active Comparator: 2<br> | Behavioral: Mindfulness Based Cognitive Therapy<br>* A novel mind body therapy that extends basic CT 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 |
| --- | --- | --- |
| Feasibility of recruitment and retention of participants |  | baseline - session 8 and 6 month follow-up | 
| Participant acceptability of novel behavioral intervention (mindfulness) |  | baseline - session 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation |  | baseline - session 8 and 6 month follow-up | 
| Exhaled CO readings |  | baseline, sessions 5 & 8 | 
| Salivary cotinine measures |  | baseline and sessions 5 & 8 | 
| Psychological Measures |  | baseline & session 8 | 
| Craving response from a smoking cue (fMRI) |  | Sessions 1,5, & 8 | 
| Reaction times on Smoking Stroop tasks (behavioral and fMRI-administered) |  | Sessions 1,5, & 8 | 
| Self Reported Measures: |  | baseline, sessions 5 & 8 | 
| Trait Self-Control Scale |  | baseline & session 8 | 
| State Ego Depletion Scale |  | baseline & session 8 | 
| Self-Efficacy Scale |  | baseline & session 8 | 
| Perceived Stress Scale |  | baseline & session 8 | 
| Positive and Negative Affect Scale |  | baseline & session 8 | 
| Difficulties in Emotional Regulation Scale |  | baseline & session 8 | 
| Snaith-Hamilton Hedonic Capacity Scale |  | baseline & session 8 | 
| Mindful Attention Awareness Scale |  | baseline & session 8 | 
| Kentucky Inventory of Mindfulness Scales |  | baseline & session 8 | 
| Mindfulness meditation practice (mindfulness participants only, time in minutes |  | sessions 1-8 | 

 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