Back to resultsEffects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone
Primary Purpose
Opioid-Related Disorders
Status
Terminated
Phase
Not Applicable
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
Inclusion Criteria: Meets criteria for opioid dependence Exclusion Criteria: Significant medical or psychiatric illness
Sites / Locations
- Johns Hopkins University (BPRU) Bayview Campus
Outcomes
Primary Outcome Measures
Physiological effects
Analog rating scale for drug effects
Secondary Outcome Measures
Full Information
NCT ID
NCT00000243
First Posted
September 20, 1999
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00000243
Brief Title
Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone
Official Title
Transitioning Patients From Methadone to Buprenorphine/Naloxone for Treating Opioid Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
Buprenorphine is a drug that may be helpful in treating opioid dependent individuals who were previously maintained on methadone. The purpose of this study is to determine the effects of different doses of buprenorphine/naloxone in treating opioid dependent individuals who were previously maintained on methadone.
Detailed Description
Buprenorphine is a mixed agonist-antagonist opioid that is being developed as a treatment for opioid dependence. Because buprenorphine is a partial mu agonist opioid, under certain conditions it is possible for buprenorphine to precipitate opioid withdrawal in opioid dependent individuals. A person with a high level of physical dependence could experience buprenorphine-related precipitated withdrawal. The purpose of this study is to test the acute effects of different doses of buprenorphine/naloxone in opioid dependent individuals maintained on methadone. The study is designed to provide dosing schedules similar to those that might be initially used in a physician's office.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
Keywords
opioid dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
16 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Primary Outcome Measure Information:
Title
Physiological effects
Title
Analog rating scale for drug effects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Meets criteria for opioid dependence
Exclusion Criteria:
Significant medical or psychiatric illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric C. Strain, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University (BPRU) Bayview Campus
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224 6823
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone
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