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Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
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
History of Changes
Results First Received: November 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizophrenia and Disorders With Psychotic Features
Tobacco Use Disorder
Interventions: Drug: Bupropion
Drug: Contingent reinforcement plus placebo
Drug: non-contingent reinforcement plus bupropion
Drug: Non-contingent reinforcement plus placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from the community, using advertisements, and were recruited from an outpatient clinic at a local VA medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants underwent telephone and in-person screening for eligibility criteria.

Reporting Groups
  Description
CM + BUP Contingent reinforcement plus bupropion
CM + PLA Contingent reinforcement plus placebo
NR + BUP Non-contingent reinforcement plus bupropion
NR + PLA Non-contingent reinforcement plus placebo

Participant Flow:   Overall Study
    CM + BUP     CM + PLA     NR + BUP     NR + PLA  
STARTED     12     16     11     13  
COMPLETED     12     16     11     13  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
CM + BUP Contingent reinforcement plus bupropion
CM + PLA Contingent reinforcement plus placebo
NR + BUP Non-contingent reinforcement plus bupropion
NR + PLA Non-contingent reinforcement plus placebo
Total Total of all reporting groups

Baseline Measures
    CM + BUP     CM + PLA     NR + BUP     NR + PLA     Total  
Number of Participants  
[units: participants]
 		  12     16     11     13     52  
Age  
[units: participants]
 		         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     12     12     10     13     47  
>=65 years     0     4     1     0     5  
Age  
[units: years]
Mean ± Standard Deviation 		  42.9  ± 11.9     46.3  ± 6.7     43.7  ± 7.3     46.9  ± 6.8     45.1  ± 8.2  
Gender  
[units: participants]
 		         
Female     4     6     3     2     15  
Male     8     10     8     11     37  
Region of Enrollment  
[units: participants]
 		         
United States     12     16     11     13     52  



  Outcome Measures
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1.  Primary:   Urinary Cotinine   [ Time Frame: 3 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Cigarettes Smoked Per Day   [ Time Frame: 3 weeks ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
none  


Results Point of Contact:  
Name/Title: Jennifer Tidey, Ph.D.
Organization: Brown University
phone: 401-863-6418
e-mail: Jennifer_Tidey@brown.edu


Publications of Results:


Responsible Party: Jennifer Tidey, 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