Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia and Disorders With Psychotic Features Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Contingent reinforcement plus bupropion

Group Type EXPERIMENTAL

Bupropion

Intervention Type DRUG

Contingent reinforcement plus bupropion (300 mg/day for 3 weeks)

2

Contingent reinforcement plus placebo

Group Type EXPERIMENTAL

Contingent reinforcement plus placebo

Intervention Type DRUG

contingent reinforcement plus placebo (3 weeks)

3

Non-contingent reinforcement plus bupropion

Group Type EXPERIMENTAL

non-contingent reinforcement plus bupropion

Intervention Type DRUG

non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks)

4

Non-contingent reinforcement plus placebo

Group Type PLACEBO_COMPARATOR

Non-contingent reinforcement plus placebo

Intervention Type DRUG

Non-contingent reinforcement plus placebo

Interventions

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Bupropion

Contingent reinforcement plus bupropion (300 mg/day for 3 weeks)

Intervention Type DRUG

Contingent reinforcement plus placebo

contingent reinforcement plus placebo (3 weeks)

Intervention Type DRUG

non-contingent reinforcement plus bupropion

non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks)

Intervention Type DRUG

Non-contingent reinforcement plus placebo

Intervention Type DRUG

Other Intervention Names

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zyban, wellbutrin zyban, wellbutrin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes