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Effects of a Voucher Incentive Program and a Pharmacological Intervention (Bupropion) on Smoking in People with Schizophrenia. - 1 - Article


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Bupropion SR

Budeprion SR; Wellbutrin SR




Clinical Trial: Effects of a Voucher Incentive Program and a Pharmacological Intervention (Bupropion) on Smoking in People with Schizophrenia. - 1

This study is not yet open for patient recruitment.
Verified by National Institute on Drug Abuse (NIDA) August 2005

Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
Brown University School of Medicine
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
Tobacco Use Disorder
 Drug: Bupropion
Phase II

MedlinePlus related topics:  Smoking

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

Official Title: Incentives Plus Bupropion for Smoking in Schizophrenics

Further Study Details: 
Primary Outcomes: Smoking Cessation

Study start: September 2003
Last follow-up: September 2007

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 salive 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 and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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 uring drug screen positive breath alcohol test, past 2 weeks use of MAO inhibitors, any form of bupropion, cimetidine, phenobarbital, phenytoin, DA agonists, anorectics, stimulants

-

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00136760


Rhode Island
      Brown University, Providence,  Rhode Island,  02912,  United States
Jennifer W. Tidey  401-444-1840    jennifer-tidey@brown.edu 

Study chairs or principal investigators

Jennifer W. Tidey,  Principal Investigator,  Brown University School of Medicine   

More Information

Study ID Numbers:  NIDA-17566-1; R01-17566-1
Last Updated:  August 26, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00136760
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-30

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Page Updated: June 1, 2005
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