Back to resultsBuprenorphine Maintenance Dose Schedule and Treatment Setting - 1
Primary Purpose
Opioid-Related Disorders, Substance-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring opioid dependence
Eligibility Criteria
Please contact site for information.
Sites / Locations
- APT Residential Services Division
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Maintenance treatment with daily medication
Maintenance treatment with thrice-weekly medication
Outcomes
Primary Outcome Measures
Opioid and cocaine use
Social and psychological functioning
AIDS risk behavior
Secondary Outcome Measures
Full Information
NCT ID
NCT00000318
First Posted
September 20, 1999
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Yale University
1. Study Identification
Unique Protocol Identification Number
NCT00000318
Brief Title
Buprenorphine Maintenance Dose Schedule and Treatment Setting - 1
Official Title
Buprenorphine Maintenance Dose Schedule and Treatment Setting: Pilot
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
December 1994 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Yale University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess optimal dosage of buprenorphine on a thrice weekly schedule in a pilot clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Substance-Related Disorders
Keywords
opioid dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Maintenance treatment with daily medication
Arm Title
2
Arm Type
Experimental
Arm Description
Maintenance treatment with thrice-weekly medication
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Intervention Description
Experimental Maintenance treatment with daily medication
Experimental Maintenance treatment with thrice-weekly medication
Primary Outcome Measure Information:
Title
Opioid and cocaine use
Time Frame
26 weeks
Title
Social and psychological functioning
Time Frame
26 weeks
Title
AIDS risk behavior
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
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
Learn more about this trial
Buprenorphine Maintenance Dose Schedule and Treatment Setting - 1
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