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NCT02044094 · ClinicalTrials.gov registry record · Phase 2
Multiple Dose Study of Blockade of Opioid Effects by Injections of Buprenorphine in Participants With Opioid Disorder
A Phase 2 study, sponsored by Indivior.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT02044094 is a Phase 2 study that has completed, run by Indivior. The registered enrollment target is 39 participants.
The verdict
NCT02044094, a Phase 2 study, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
This is a multiple-dose study in non-treatment seeking male and female subjects with moderate to severe opioid use disorder who meet criteria from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) to evaluate the effectiveness of RBP-6000 to block the effects of exogenous opioids. The primary objective of this study was to demonstrate that the "Drug Liking" visual analog scale (VAS) measured after challenge with 6 mg (Dose 1) and 18 mg (Dose 2) hydromorphone was noninferior to the "Drug Liking" visual analog scale (VAS) measured after challenge with placebo at Weeks 1-4 post first injection of subcutaneous buprenorphine 300 mg (RBP-6000).
Interventions
- DRUG placebo
- DRUG Buprenorphine
- DRUG buprenorphine and naloxone
- DRUG hydromorphone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2013-11 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02044094
The ClinicalTrials.gov registry entry for NCT02044094 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indivior, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.
NCT02044094 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02044094 about?
NCT02044094 is a clinical study titled "Multiple Dose Study of Blockade of Opioid Effects by Injections of Buprenorphine in Participants With Opioid Disorder". This is a multiple-dose study in non-treatment seeking male and female subjects with moderate to severe opioid use disorder who meet criteria from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) to evaluate the effectiveness of RBP-6000 to block the effects of exogenou...
What is the current status of trial NCT02044094?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2013-11. Estimated completion is 2014-07.
What interventions are being tested in trial NCT02044094?
The interventions under investigation include: placebo (DRUG), Buprenorphine (DRUG), buprenorphine and naloxone (DRUG), hydromorphone (DRUG).
Who is sponsoring clinical trial NCT02044094?
This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.
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