Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jennifer Tidey, Brown University
ClinicalTrials.gov Identifier:
NCT00136760
First received: August 25, 2005
Last updated: April 3, 2013
Last verified: April 2013

August 25, 2005
April 3, 2013
September 2003
March 2009   (final data collection date for primary outcome measure)
Urinary Cotinine [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Urinary Cotinine levels at Week 4 (average of last 3 study visits)
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 ]
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia and Disorders With Psychotic Features
  • Tobacco Use Disorder
  • Drug: Bupropion
    Contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
    Other Name: zyban, wellbutrin
  • Drug: Contingent reinforcement plus placebo
    contingent reinforcement plus placebo (3 weeks)
  • Drug: non-contingent reinforcement plus bupropion
    non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
    Other Name: zyban, wellbutrin
  • Drug: Non-contingent reinforcement plus placebo
    Non-contingent reinforcement plus placebo
  • Experimental: 1
    Contingent reinforcement plus bupropion
    Intervention: Drug: Bupropion
  • Experimental: 2
    Contingent reinforcement plus placebo
    Intervention: Drug: Contingent reinforcement plus placebo
  • Experimental: 3
    Non-contingent reinforcement plus bupropion
    Intervention: Drug: non-contingent reinforcement plus bupropion
  • Placebo Comparator: 4
    Non-contingent reinforcement plus placebo
    Intervention: Drug: Non-contingent reinforcement plus placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
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
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00136760
NIDA-17566-1, R01DA017566, R01-17566-1
Yes
Jennifer Tidey, Brown University
Brown University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Jennifer W. Tidey Brown University
Brown University
April 2013

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