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Effect of Bupropion on Smoking Behavior in Smokers With Schizophrenia

Phase 2
Completed
Conditions
Schizophrenia
Tobacco Use Disorder
Interventions
Drug: 300 mg/day bupropion-sr
Drug: 0 mg/day bupropion-sr
Registration Number
NCT00218231
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
1300 mg/day bupropion-sr300 mg/day bupropion-sr
20 mg/day bupropion-sr0 mg bupropion-sr
Primary Outcome Measures
NameTimeMethod
Smoking behaviorafter 5 hrs abstinence
Secondary Outcome Measures
NameTimeMethod
urge to smokeafter 5 hrs abstinence
nicotine withdrawal symptomsafter 5 hrs withdrawal
Adverse eventsongoing

Trial Locations

Locations (2)

Providence VA Medical Center, RI

🇺🇸

Providence, Rhode Island, United States

Brown University

🇺🇸

Providence, Rhode Island, United States

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