- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00134875
Assessing Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers
Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224 6823
- Johns Hopkins University (BPRU) Bayview Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Opioid agonist effects
Time Frame: 3.5 hours
|
3.5 hours
|
Physiologic measures
Time Frame: 3.5 hours
|
3.5 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Eric C. Strain, M.D., Johns Hopkins University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Buprenorphine
- Naloxone
- Buprenorphine, Naloxone Drug Combination
Other Study ID Numbers
- NIDA-08045-3
- DPMC (Other Identifier: NIDA)
- R01-08045-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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