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| Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Brown University |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00136760 |
Purpose
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.
| Condition | Intervention | Phase |
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Schizophrenia and Disorders With Psychotic Features Tobacco Use Disorder |
Drug: Bupropion Drug: Contingent reinforcement plus placebo Drug: non-contingent reinforcement plus bupropion Drug: Non-contingent reinforcement plus placebo |
Phase II |
| MedlinePlus related topics: | Schizophrenia Smoking |
| Drug Information available for: | Bupropion hydrochloride Bupropion |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
| Official Title: | Incentives Plus Bupropion for Smoking in Schizophrenics |
| Estimated Enrollment: | 128 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
Contingent reinforcement plus bupropion
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Drug: Bupropion
Contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
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2: Experimental
Contingent reinforcement plus placebo
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Drug: Contingent reinforcement plus placebo
contingent reinforcement plus placebo (3 weeks)
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3: Experimental
Non-contingent reinforcement plus bupropion
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Drug: non-contingent reinforcement plus bupropion
non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
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4: Placebo Comparator
Non-contingent reinforcement plus placebo
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Drug: Non-contingent reinforcement plus placebo
Non-contingent reinforcement plus placebo
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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.
Eligibility
| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Rhode Island | |||||
| Brown University | Recruiting | ||||
| Providence, Rhode Island, United States, 02912 | |||||
| Contact: Jennifer W. Tidey, Ph.D. 401-863-6418 Jennifer_Tidey@brown.edu | |||||
| National Institute on Drug Abuse (NIDA) |
| Brown University |
| Principal Investigator: | Jennifer W. Tidey | Brown University |
More Information
| Responsible Party: | Brown University ( Jennifer W. Tidey ) |
| Study ID Numbers: | NIDA-17566-1, R01-17566-1 |
| First Received: | August 25, 2005 |
| Last Updated: | August 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00136760 |
| Health Authority: | United States: Federal Government |
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