Back to resultsCombining Behavioral Treatment With Agonist Maintenance - 1
Primary Purpose
Cocaine-Related Disorders, Opioid-Related Disorders, Substance-Related Disorders
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
methadone
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring Cocaine-Related Disorders, Opioid-Related Disorders, Substance-Related Disorders
Eligibility Criteria
Please contact site for information.
Sites / Locations
- APT Residential Services Division
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
Methadone + CM (contingency management)
methadone + VC (voucher control)
Buprenorphine + CM
Buprenorphine + VC
Outcomes
Primary Outcome Measures
Depression
Withdrawal symptoms
Opioid and cocaine use
Social and psychological functioning
AIDS risk behavior
Secondary Outcome Measures
Full Information
NCT ID
NCT00000311
First Posted
September 20, 1999
Last Updated
January 12, 2018
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00000311
Brief Title
Combining Behavioral Treatment With Agonist Maintenance - 1
Official Title
Combining Behavioral Treatment With Agonist Maintenance
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 1995 (undefined)
Primary Completion Date
February 1999 (Actual)
Study Completion Date
February 1999 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate whether the community reinforcement approach (CRA) plus contingency management (CM) is more effective overall than CRA only in reducing illicit opioid and cocaine use during agonist maintenance treatment and at 3 and 6 month follow-up after completion of study protocol, and to compare the efficacy of maintenance on buprenorphine to methadone when maintenance is combined with CRA only or CRA plus CM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders, Opioid-Related Disorders, Substance-Related Disorders
Keywords
Cocaine-Related Disorders, Opioid-Related Disorders, Substance-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Methadone + CM (contingency management)
Arm Title
2
Arm Type
Experimental
Arm Description
methadone + VC (voucher control)
Arm Title
3
Arm Type
Experimental
Arm Description
Buprenorphine + CM
Arm Title
4
Arm Type
Experimental
Arm Description
Buprenorphine + VC
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Intervention Description
Medication and Behavioral
Intervention Type
Drug
Intervention Name(s)
methadone
Intervention Description
medication and behavioral
Primary Outcome Measure Information:
Title
Depression
Time Frame
24 weeks
Title
Withdrawal symptoms
Title
Opioid and cocaine use
Title
Social and psychological functioning
Title
AIDS risk behavior
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Please contact site for information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Schottenfeld, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
APT Residential Services Division
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
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Combining Behavioral Treatment With Agonist Maintenance - 1
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