Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia

Brown University

Status and phase: Completed; Phase 2

Conditions: Tobacco Use Disorder; Schizophrenia and Disorders With Psychotic Features

Treatments: Drug: Bupropion; Drug: Contingent reinforcement plus placebo; Drug: non-contingent reinforcement plus bupropion; Drug: Non-contingent reinforcement plus placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00136760

R01-17566-1

NIDA-17566-1

R01DA017566 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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57 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Contingent reinforcement plus bupropion

Treatment:

Drug: Bupropion

2

Experimental group

Description:

Contingent reinforcement plus placebo

Treatment:

Drug: Contingent reinforcement plus placebo

3

Experimental group

Description:

Non-contingent reinforcement plus bupropion

Treatment:

Drug: non-contingent reinforcement plus bupropion

4

Placebo Comparator group

Description:

Non-contingent reinforcement plus placebo

Treatment:

Drug: Non-contingent reinforcement plus placebo