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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
  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
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Incentives Plus Bupropion for Smoking in Schizophrenics

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Urinary Cotinine [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Urinary Cotinine levels at Week 4 (average of last 3 study visits)


Secondary Outcome Measures:
  • Cigarettes Smoked Per Day [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: September 2003
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Contingent reinforcement plus bupropion
Drug: Bupropion
Contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
Other Name: zyban, wellbutrin
Experimental: 2
Contingent reinforcement plus placebo
Drug: Contingent reinforcement plus placebo
contingent reinforcement plus placebo (3 weeks)
Experimental: 3
Non-contingent reinforcement plus bupropion
Drug: non-contingent reinforcement plus bupropion
non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
Other Name: zyban, wellbutrin
Placebo Comparator: 4
Non-contingent reinforcement plus placebo
Drug: Non-contingent reinforcement plus placebo
Non-contingent reinforcement plus placebo

Detailed Description:

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
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136760

Locations
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Jennifer W. Tidey Brown University
  More Information

Publications:
Responsible Party: Jennifer Tidey, Associate Professor (Research), Dept Psychiatry and Human Behavior, Brown University
ClinicalTrials.gov Identifier: NCT00136760     History of Changes
Other Study ID Numbers: NIDA-17566-1, R01DA017566, R01-17566-1
Study First Received: August 25, 2005
Results First Received: November 16, 2012
Last Updated: April 3, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Disease
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes
Substance-Related Disorders
Bupropion
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014