Effects of a Voucher Incentive Program and a Pharmacological Intervention (Bupropion) on Smoking in People With Schizophrenia. - 1

Condition(s) targeted: Schizophrenia and Disorders With Psychotic Features; Tobacco Use Disorder

Intervention: Bupropion (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Jennifer W. Tidey, Principal Investigator, Affiliation: Brown University

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.

Official title: Incentives Plus Bupropion for Smoking in Schizophrenics

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

Primary outcome: Smoking Behavior

Secondary outcome:

Psychiatric symptoms

Withdrawal severity

Adverse events

7 day point prevalence of cigarette abstinence

Detailed description: 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 salive 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 uring drug screen positive breath alcohol test, past 2 weeks use of MAO inhibitors, any form of bupropion, cimetidine, phenobarbital, phenytoin, DA agonists, anorectics, stimulants

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Brown University, Providence, Rhode Island 02912, United States; Recruiting
Jennifer W. Tidey, Phone: 401-444-1840, Email: jennifer-tidey@brown.edu

Starting date: September 2003
Ending date: September 2007
Last updated: November 3, 2005