Back to resultsAlternate-Day Buprenorphine Administration. Phase I - 3
Primary Purpose
Opioid-Related Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders
Eligibility Criteria
Please contact site for information.
Sites / Locations
- Treatment Research Center
Outcomes
Primary Outcome Measures
Drug use
Opioid withdrawal
Opioid agonist effects
Dose identification
Pupil diameter
Secondary Outcome Measures
Full Information
NCT ID
NCT00000221
First Posted
September 20, 1999
Last Updated
June 23, 2005
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Vermont
1. Study Identification
Unique Protocol Identification Number
NCT00000221
Brief Title
Alternate-Day Buprenorphine Administration. Phase I - 3
Official Title
Alternate-Day Buprenorphine Administration. Phase I
Study Type
Interventional
2. Study Status
Record Verification Date
November 1993
Overall Recruitment Status
Completed
Study Start Date
April 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Vermont
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine if two times a subject's daily maintenance dose will hold for 48 hours without changes in agonist and antagonist effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Enrollment
0 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Primary Outcome Measure Information:
Title
Drug use
Title
Opioid withdrawal
Title
Opioid agonist effects
Title
Dose identification
Title
Pupil diameter
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Please contact site for information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren Bickel, Ph.D.
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Treatment Research Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8164503
Citation
Amass L, Bickel WK, Higgins ST, Badger GJ. Alternate-day dosing during buprenorphine treatment of opioid dependence. Life Sci. 1994;54(17):1215-28. doi: 10.1016/0024-3205(94)00848-5.
Results Reference
background
Learn more about this trial
Alternate-Day Buprenorphine Administration. Phase I - 3
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