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Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia
This study is currently recruiting participants.
Study NCT00136760   Information provided by National Institute on Drug Abuse (NIDA)
First Received: August 25, 2005   Last Updated: August 25, 2008   History of Changes

August 25, 2005
August 25, 2008
September 2003
March 2009   (final data collection date for primary outcome measure)
Urinary cotinine [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Smoking Cessation
Complete list of historical versions of study NCT00136760 on ClinicalTrials.gov Archive Site
  • Cigarettes smoked per day [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Withdrawal severity [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Craving [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
  • Psychiatric symptoms
  • Withdrawal severity
  • Adverse events
  • 7 day point prevalence of cigarette abstinence
 
Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia
Incentives Plus Bupropion for Smoking in Schizophrenics

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.

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.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
  • 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
  • Experimental: Contingent reinforcement plus bupropion
  • Experimental: Contingent reinforcement plus placebo
  • Experimental: Non-contingent reinforcement plus bupropion
  • Placebo Comparator: Non-contingent reinforcement plus placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
128
March 2009
March 2009   (final data collection date for primary outcome measure)

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

Both
18 Years to 80 Years
Yes
 
United States
 
NCT00136760
Jennifer W. Tidey, Brown University
NIDA-17566-1, R01-17566-1
National Institute on Drug Abuse (NIDA)
Brown University
Principal Investigator: Jennifer W. Tidey Brown University
National Institute on Drug Abuse (NIDA)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP