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Completed

NCT Number: NCT00136760

Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brown University

Providence, Rhode Island, 02912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bupropion

Drug

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

Other names: zyban, wellbutrin

Contingent reinforcement plus placebo

Drug

contingent reinforcement plus placebo (3 weeks)

non-contingent reinforcement plus bupropion

Drug

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

Other names: zyban, wellbutrin

Non-contingent reinforcement plus placebo

Drug

Non-contingent reinforcement plus placebo

Primary outcomes

  1. Urinary Cotinine

    Time frame: 3 weeks

    Urinary Cotinine levels at Week 4 (average of last 3 study visits)

Secondary outcomes

  1. Cigarettes Smoked Per Day

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Incentives Plus Bupropion for Smoking in Schizophrenics

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Aug 29, 2005
Registry last updated
Oct 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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