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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: August 2006

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.

Intervention(s) in this Clinical Trial

• Drug: 300 mg/day bupropion-sr
  • 300 mg/day for 1 week
• Drug: 0 mg/day bupropion-sr
  • 0 mg/day bupropion-sr

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 300 mg/day bupropion-sr
• Placebo Comparator: 2
  • 0 mg bupropion-sr

Primary Measures

• Smoking behavior
  • Time Frame: after 5 hrs abstinence
    Safety Issue?: No

Secondary Measures

• Adverse events
  • Time Frame: ongoing
    Safety Issue?: Yes
• urge to smoke
  • Time Frame: after 5 hrs abstinence
    Safety Issue?: No
• nicotine withdrawal symptoms
  • Time Frame: after 5 hrs withdrawal
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Jennifer W. Tidey Principal Investigator Brown University  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00218231

Study ID Number: NIDA-14002-2

ClinicalTrials.gov Identifier: NCT00218231

Health Authority: United States: Federal Government