Back to resultsBuprenorphine Dose Alteration Study - 1
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
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: skin temperature
Secondary Outcome Measures
Full Information
NCT ID
NCT00000219
First Posted
September 20, 1999
Last Updated
May 5, 2016
Sponsor
University of Vermont
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00000219
Brief Title
Buprenorphine Dose Alteration Study - 1
Official Title
Buprenorphine Dose Alteration Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 1992
Overall Recruitment Status
Completed
Study Start Date
December 1991 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Vermont
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to examine the effects in buprenorphine dose alterations in opioid dependent individuals being maintained on buprenorphine.
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
Masking
Double
Enrollment
0 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Primary Outcome Measure Information:
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: skin temperature
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
41 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
In preparation. In preparation.
Results Reference
background
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Buprenorphine Dose Alteration Study - 1
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