Bupropion and Cigarette-Related Cues in Smokers

Study Overview
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Brief Summary
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Randomized, double-blind, before-after controlled trial to assess changes in regional brain activation in response to cigarette-related cues from before to after treatment with bupropion (vs placebo).

Official Title
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Effect of Bupropion Treatment on Brain Activation Induced by Cigarette-Related Cues in Smokers

Conditions
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Smoking, Smoking, Tobacco

Intervention / Treatment
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* Drug: Bupropion
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment-seeking cigarette smoker Meet DSM-IV criteria for nicotine dependence Negative result on urine test for drug use during screening Exclusion Criteria: History of any Axis I psychiatric diagnosis other than nicotine dependence Medical conditions that might affect brain function Current use of medications that could alter brain function Pregnancy Current illicit drug use other than occasional use of marijuana

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

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, before-after controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupropion<br>Participants assigned to 150mg of bupropion daily for the first 3 days, followed by titration up to 2 pills daily, separated by 8 hours, for the remaining 8 weeks of treatment. | Drug: Bupropion<br>* Bupropion 150 mg sustained release<br>* Other names: Wellbutrin;|
| Placebo Comparator: Placebo<br>Participants assigned to pill placebo daily for the first 3 days, followed by titration up to 2 pills daily, separated by 8 hours, for the remaining 8 weeks of treatment. | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving ratings | Participants were instructed to respond from 1 (definitely not) to 5 (definitely) on the question, I crave a cigarette right now, after viewing video cues. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled carbon monoxide (CO) | Participants were asked to hold their breath for as long as possible, ideally 15 seconds, then to breathe out slowly into the mouthpiece of a CO monitor, aiming to empty the lungs completely. | 8 weeks | 
| Cigarettes per day | Self-reported number of cigarettes smoked daily during the past 7 days [??] | 8 weeks | 
| Fagerström Test for Nicotine Dependence (FTND) | The FTND contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. | 8 weeks |