Effect of Bupropion on Smoking Behavior in Smokers With Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-08-31

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.

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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.

Conditions

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Schizophrenia Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

300 mg/day bupropion-sr

Group Type EXPERIMENTAL

300 mg/day bupropion-sr

Intervention Type DRUG

300 mg/day for 1 week

2

0 mg bupropion-sr

Group Type PLACEBO_COMPARATOR

0 mg/day bupropion-sr

Intervention Type DRUG

0 mg/day bupropion-sr

Interventions

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300 mg/day bupropion-sr

300 mg/day for 1 week

Intervention Type DRUG

0 mg/day bupropion-sr

Intervention Type DRUG

Other Intervention Names

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zyban, wellbutrin placebo

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes