Official Title: “Incentives Plus Bupropion for Smoking in Schizophrenics”

There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. The aims of this study are to investigate the separate and combined effects of bupropion and a voucher incentive program on smoking in people with schizophrenia.

Study Type: Interventional

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

Study Primary Completion Date: March 2009

There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. In this study, we are investigating whether the combination of bupropion (also called Zyban and Wellbutrin) and a behavioral treatment program (contingent vouchers) can reduce smoking in people with schizophrenia. This is a 3-week study aimed to investigate the feasibility of this treatment approach. Participants are randomly assigned to bupropion (300 mg/day, in 2 divided doses) or placebo. After one week on medication, participants are randomly assigned to the active behavioral treatment (contingent vouchers) or the control treatment (non-contingent vouchers). Over a 3-week period, participants come to the study site about 2-3 times per week, and provide information about their recent smoking and nicotine withdrawal symptoms. They also give saliva and urine samples that are analyzed for levels of cotinine, a nicotine metabolite. Participants in the active behavioral treatment group receive gift cards to local grocery stores when their cotinine levels indicate that they have reduced their smoking. Participants in the control behavioral treatment group receive gift cards regardless of cotinine level. Any participant who significantly reduces their smoking at the end of the trial is followed up 2 and 4 weeks after the end of the trial too see if they have sustained these smoking reductions. If we have favorable results from this trial, we will expand it into a smoking treatment program.

Intervention(s) in this Clinical Trial

• Drug: Bupropion
  • Contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
• Drug: Contingent reinforcement plus placebo
  • contingent reinforcement plus placebo (3 weeks)
• Drug: non-contingent reinforcement plus bupropion
  • non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
• Drug: Non-contingent reinforcement plus placebo
  • Non-contingent reinforcement plus placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Contingent reinforcement plus bupropion
• Experimental: 2
  • Contingent reinforcement plus placebo
• Experimental: 3
  • Non-contingent reinforcement plus bupropion
• Placebo Comparator: 4
  • Non-contingent reinforcement plus placebo

Primary Measures

• Urinary cotinine
  • Time Frame: 3 weeks
    Safety Issue?: No

Secondary Measures

• Cigarettes smoked per day
  • Time Frame: 3 weeks
    Safety Issue?: No
• Withdrawal severity
  • Time Frame: 3 weeks
    Safety Issue?: No
• Craving
  • Time Frame: 3 weeks
    Safety Issue?: No
• Adverse events
  • Time Frame: ongoing
    Safety Issue?: Yes

Inclusion Criteria:

• Diagnosis of schizophrenia or schizoaffective disorder, smoke 20-50 cpd, clinically stable on antipsychotic and antidepressant medications

Exclusion Criteria:

• Pregnant/nursing women, seizure disorder, lowered seizure threshold due to other medical conditions, positive urine drug screen positive breath alcohol test, past 2 weeks use of MAO inhibitors, any form of bupropion, cimetidine, phenobarbital, phenytoin, DA agonists, anorectics, stimulants

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 July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00136760

Study ID Number: NIDA-17566-1

ClinicalTrials.gov Identifier: NCT00136760

Health Authority: United States: Federal Government