Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia

October 5, 2015 updated by: Jennifer Tidey, Brown University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Brown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Contingent reinforcement plus bupropion
Drug: Bupropion
Contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
Other Names:
  • 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 Names:
  • zyban, wellbutrin
Placebo Comparator: 4
Non-contingent reinforcement plus placebo
Drug: Non-contingent reinforcement plus placebo
Non-contingent reinforcement plus placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Cotinine
Time Frame: 3 weeks
Urinary Cotinine levels at Week 4 (average of last 3 study visits)
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Cigarettes Smoked Per Day
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Jennifer W. Tidey, Brown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 29, 2005

Study Record Updates

Last Update Posted (Estimate)

October 7, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-17566-1
  • R01DA017566 (U.S. NIH Grant/Contract)
  • R01-17566-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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