Assessing Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers
Primary Purpose
Opioid-Related Disorders
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine/naloxone
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring opioid dependence
Eligibility Criteria
Inclusion Criteria: Non-dependent opioid abuser Actively abusing opioids by injection Exclusion Criteria: Opioid dependence Signs or symptoms of opioid withdrawal, once admitted to residential unit
Sites / Locations
- Johns Hopkins University (BPRU) Bayview Campus
Outcomes
Primary Outcome Measures
Opioid agonist effects
Physiologic measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00134875
First Posted
August 23, 2005
Last Updated
January 11, 2017
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00134875
Brief Title
Assessing Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers
Official Title
Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Terminated
Study Start Date
December 2000 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
Brief Summary
Buprenorphine, a treatment for opioid dependence, can be mixed with another drug, naloxone, to limit abuse potential. Parenteral administration (intravenous or intramuscular injection) of buprenorphine/naloxone causes withdrawal symptoms in opioid dependent individuals. However, naloxone does not cause withdrawal symptoms in non-dependent opioid abusers. This study will investigate whether naloxone decreases the opioid agonist effect from injected buprenorphine, hence decreasing the abuse potential of buprenorphine/naloxone, in non-dependent opioid abusers.
Detailed Description
Naloxone has been combined with buprenorphine to decrease the parenteral abuse potential of buprenorphine in opioid dependent individuals through the mechanism of naloxone-precipitated withdrawal. While naloxone will not precipitate withdrawal in individuals who are not physically dependent on opioids, it is possible naloxone might attenuate buprenorphine's agonist effects, especially if administered parenterally. The purpose of this study is to assess the effect of sublingual (SL) and intramuscular (IM) buprenorphine and buprenorphine/naloxone in non-dependent opioid abusers.
Participants will stay on a research ward and will undergo challenge sessions twice per week. The following conditions will be tested: placebo; IM hydromorphone (2 and 4 mg; an opioid agonist positive control condition); SL buprenorphine (4, 8, and 16 mg); IM buprenorphine (4, 8, and 16 mg); SL buprenorphine/naloxone(4/1, 8/2, and 16/4 mg); and IM buprenorphine/naloxone (4/1, 8/2, and 16/4 mg). During challenge sessions, physiological status will be recorded continuously and tasks assessing psychomotor, subjective, and objective status will be performed repeatedly.
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
ParticipantCare Provider
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Buprenorphine/naloxone
Intervention Description
Acute doses of buprenorphine/naloxone in each experimental test session. Doses delivered by either sublingual or parenteral routes, and are: 4/1, 8/2, 16/4 mg.
Primary Outcome Measure Information:
Title
Opioid agonist effects
Time Frame
3.5 hours
Title
Physiologic measures
Time Frame
3.5 hours
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:
Non-dependent opioid abuser
Actively abusing opioids by injection
Exclusion Criteria:
Opioid dependence
Signs or symptoms of opioid withdrawal, once admitted to residential unit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric C. Strain, M.D.
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
Assessing Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers
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