Effect of Bupropion on Smoking Behavior in Smokers With Schizophrenia

Study Overview
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Brief Summary
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Many individuals with schizophrenia smoke cigarettes but little is known about the factors that control smoking in people with schizophrenia. The purpose of this trial is to evaluate how bupropion, an antidepressant medication, affects smoking behaviors in individuals with schizophrenia who smoke.

Detailed Description
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There is a high prevalence of cigarette smoking among people with schizophrenia and few smoking cessation interventions have been developed for these individuals. Bupropion is an antidepressant medication commonly used to treat smoking in smokers without psychiatric disorder. This study compares how smokers with schizophrenia and smokers without psychiatric illness respond to bupropion (0, 300 mg/day). Participants will be randomly assigned to receive either bupropion or placebo. Study visits will occur after one-week treatment with placebo or bupropion. During study sessions, participants will come to the laboratory at 9 am and will remain abstinent in the laboratory for 5 hrs. Participants will then be assessed for craving and withdrawal symptoms after viewing and handling neutral cues and smoking cues. After that, participants will have a 90-min period to smoke, and smoking topography will be measured.

Official Title
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Transdermal Nicotine and Bupropion-SR in Schizophrenics (Study 2)

Conditions
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Schizophrenia, Tobacco Use Disorder

Intervention / Treatment
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* Drug: 300 mg/day bupropion-sr
* Drug: 0 mg/day bupropion-sr


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with schizophrenia or schizo-affective disorder Smokes between 20 and 50 cigarettes per day Moderate to high nicotine dependence score Interest in quitting smoking Exclusion Criteria: Currently trying to quit smoking Seizure disorder or lowered seizure threshold due to anorexia, bulimia, head trauma, diabetes with insulin, or hypoglycemics Alcohol or drug use disorders Requires certain medications Pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>300 mg/day bupropion-sr | Drug: 300 mg/day bupropion-sr<br>* 300 mg/day for 1 week<br>* Other names: zyban, wellbutrin;|
| Placebo Comparator: 2<br>0 mg bupropion-sr | Drug: 0 mg/day bupropion-sr<br>* 0 mg/day bupropion-sr<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking behavior |  | after 5 hrs abstinence | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | ongoing | 
| urge to smoke |  | after 5 hrs abstinence | 
| nicotine withdrawal symptoms |  | after 5 hrs withdrawal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, tobacco dependence, nicotine