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Effect of Bupropion on Smoking Behavior in Smokers With Schizophrenia

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 2

Conditions

Tobacco Use Disorder
Schizophrenia

Treatments

Drug: 0 mg/day bupropion-sr
Drug: 300 mg/day bupropion-sr

Study type

Interventional

Funder types

NIH

Identifiers

NCT00218231
NIDA-14002-2
R01-14002-2
DPMC

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

48 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
300 mg/day bupropion-sr
Treatment:
Drug: 300 mg/day bupropion-sr
2
Placebo Comparator group
Description:
0 mg bupropion-sr
Treatment:
Drug: 0 mg/day bupropion-sr

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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