Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	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
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

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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia Smoking

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Urinary cotinine [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

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
1: Experimental Contingent reinforcement plus bupropion	Drug: Bupropion Contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
2: Experimental Contingent reinforcement plus placebo	Drug: Contingent reinforcement plus placebo contingent reinforcement plus placebo (3 weeks)
3: Experimental Non-contingent reinforcement plus bupropion	Drug: non-contingent reinforcement plus bupropion non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
4: Placebo Comparator 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

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

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

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Brown University

Investigators

Principal Investigator:

Jennifer W. Tidey

Brown University

More Information

No publications provided

Responsible Party:	Brown University ( Jennifer W. Tidey )
Study ID Numbers:	NIDA-17566-1, R01-17566-1
Study First Received:	August 25, 2005
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00136760 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Tobacco Use Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Pharmacologic Actions
Schizophrenia

Pathologic Processes
Mental Disorders
Therapeutic Uses
Bupropion
Substance-Related Disorders
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features
Antidepressive Agents

ClinicalTrials.gov processed this record on November 27, 2009