Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia

Phase 2

Completed

• Conditions: Schizophrenia and Disorders With Psychotic Features; Tobacco Use Disorder
• Interventions: Drug: Bupropion; Drug: Contingent reinforcement plus placebo; Drug: non-contingent reinforcement plus bupropion; Drug: Non-contingent reinforcement plus placebo

• Registration Number: NCT00136760
• Lead Sponsor: Brown University

Brief Summary

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.

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 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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-29
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2012-11-16
• Results First Submitted QC: 2012-11-19
• Results First Posted: 2012-12-17
• Status Verified: 2013-04
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Bupropion	Contingent reinforcement plus bupropion
2	Contingent reinforcement plus placebo	Contingent reinforcement plus placebo
3	non-contingent reinforcement plus bupropion	Non-contingent reinforcement plus bupropion
4	Non-contingent reinforcement plus placebo	Non-contingent reinforcement plus placebo

Primary Outcome Measures

Name	Time	Method
Urinary Cotinine	3 weeks	Urinary Cotinine levels at Week 4 (average of last 3 study visits)

Secondary Outcome Measures

Name	Time	Method
Cigarettes Smoked Per Day	3 weeks

Trial Locations

Locations (1)

Brown University; 🇺🇸 Providence, Rhode Island, United States