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Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia

Primary Purpose

Schizophrenia and Disorders With Psychotic Features, Tobacco Use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupropion
Contingent reinforcement plus placebo
non-contingent reinforcement plus bupropion
Non-contingent reinforcement plus placebo
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia and Disorders With Psychotic Features focused on measuring tobacco

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brown University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Contingent reinforcement plus bupropion

Contingent reinforcement plus placebo

Non-contingent reinforcement plus bupropion

Non-contingent reinforcement plus placebo

Outcomes

Primary Outcome Measures

Urinary Cotinine
Urinary Cotinine levels at Week 4 (average of last 3 study visits)

Secondary Outcome Measures

Cigarettes Smoked Per Day

Full Information

First Posted
August 25, 2005
Last Updated
October 5, 2015
Sponsor
Brown University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00136760
Brief Title
Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia
Official Title
Incentives Plus Bupropion for Smoking in Schizophrenics
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia and Disorders With Psychotic Features, Tobacco Use Disorder
Keywords
tobacco

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Contingent reinforcement plus bupropion
Arm Title
2
Arm Type
Experimental
Arm Description
Contingent reinforcement plus placebo
Arm Title
3
Arm Type
Experimental
Arm Description
Non-contingent reinforcement plus bupropion
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Non-contingent reinforcement plus placebo
Intervention Type
Drug
Intervention Name(s)
Bupropion
Other Intervention Name(s)
zyban, wellbutrin
Intervention Description
Contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
Intervention Type
Drug
Intervention Name(s)
Contingent reinforcement plus placebo
Intervention Description
contingent reinforcement plus placebo (3 weeks)
Intervention Type
Drug
Intervention Name(s)
non-contingent reinforcement plus bupropion
Other Intervention Name(s)
zyban, wellbutrin
Intervention Description
non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
Intervention Type
Drug
Intervention Name(s)
Non-contingent reinforcement plus placebo
Intervention Description
Non-contingent reinforcement plus placebo
Primary Outcome Measure Information:
Title
Urinary Cotinine
Description
Urinary Cotinine levels at Week 4 (average of last 3 study visits)
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Cigarettes Smoked Per Day
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer W. Tidey
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21475970
Citation
Tidey JW, Rohsenow DJ, Kaplan GB, Swift RM, Reid N. Effects of contingency management and bupropion on cigarette smoking in smokers with schizophrenia. Psychopharmacology (Berl). 2011 Sep;217(2):279-87. doi: 10.1007/s00213-011-2282-8. Epub 2011 Apr 8.
Results Reference
result
PubMed Identifier
22197799
Citation
Tidey JW. Using incentives to reduce substance use and other health risk behaviors among people with serious mental illness. Prev Med. 2012 Nov;55 Suppl(Suppl):S54-60. doi: 10.1016/j.ypmed.2011.11.010. Epub 2011 Dec 9.
Results Reference
result

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Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia

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