Back to resultsAlternate-Day Buprenorphine. Phase V - 6
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
Subjective dose estimate
Drug effect characteristics: ARCI
Physiological changes in: pupil diameter
Physiological changes in: blood pressure
Physiological changes in: heart rate
Physiological changes in: respiration
Physiological changes in: bup plasma levels
Secondary Outcome Measures
Full Information
NCT ID
NCT00000224
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
NCT00000224
Brief Title
Alternate-Day Buprenorphine. Phase V - 6
Official Title
Alternate-Day Buprenorphine. Phase V
Study Type
Interventional
2. Study Status
Record Verification Date
April 1996
Overall Recruitment Status
Completed
Study Start Date
February 1993 (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 evaluate buprenorphine blockade challenge.
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
Subjective dose estimate
Title
Drug effect characteristics: ARCI
Title
Physiological changes in: pupil diameter
Title
Physiological changes in: blood pressure
Title
Physiological changes in: heart rate
Title
Physiological changes in: respiration
Title
Physiological changes in: bup plasma levels
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
49 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:
Citation
Bickel, Amass, Badger (in preparation) A double-blind controlled trial of buprenorphine dosing every 72 hours in opioid dependenct humans. Bickel, Amass, Badger (in preparation) A double-blind controlled trial of buprenorphine dosing every 72 hours in opioid dependent humans.
Results Reference
background
Learn more about this trial
Alternate-Day Buprenorphine. Phase V - 6
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