Skip to content

Effect of Bupropion on Smoking Behavior in Smokers With Schizophrenia

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00218231
Enrollment
48
Registered
2005-09-22
Start date
2004-01-31
Completion date
2006-08-31
Last updated
2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, Tobacco Use Disorder

Keywords

schizophrenia, tobacco dependence, nicotine

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.

Interventions

DRUG300 mg/day bupropion-sr

300 mg/day for 1 week

DRUG0 mg/day bupropion-sr

0 mg/day bupropion-sr

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Smoking behaviorafter 5 hrs abstinence

Secondary

MeasureTime frame
Adverse eventsongoing
urge to smokeafter 5 hrs abstinence
nicotine withdrawal symptomsafter 5 hrs withdrawal

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026