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NCT01738503 · ClinicalTrials.gov registry record · Phase 2
Multiple Dose Pharmacokinetics Depot Buprenorphine in Opioid-Dependent Subjects
A Phase 2 study, sponsored by Indivior.
- Completed
- Registry status
- Phase 2
- Development phase
- 124
- Enrollment target
NCT01738503 is a Phase 2 study that has completed, run by Indivior. The registered enrollment target is 124 participants.
The verdict
NCT01738503, a Phase 2 study, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 124 participants
- Enrollment target
Study Summary
This is an open-label study in treatment seeking opioid-dependent subjects for safety, tolerability, pharmacokinetics (PK), efficacy markers, and opioid receptor availability of subcutaneous injections of depot buprenorphine after induction and stabilization of treatment seeking subjects onto Subutex. Subjects were planned to receive 4 subcutaneous (SC) injections of RBP-6000 separated by 28 days (Cohorts 1-5) or 6 SC injections of RBP-6000 separated by 28 days (Cohort 6) after a 13-day induction and dose stabilisation period on SUBUTEX Sublingual (SL) tablet at dose levels of 8-24 mg.
Interventions
- DRUG RBP-6000
- DRUG Subutex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01738503
The ClinicalTrials.gov registry entry for NCT01738503 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 124 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 2 interventions - of which RBP-6000 is the first listed.
NCT01738503 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01738503 about?
NCT01738503 is a clinical study titled "Multiple Dose Pharmacokinetics Depot Buprenorphine in Opioid-Dependent Subjects". This is an open-label study in treatment seeking opioid-dependent subjects for safety, tolerability, pharmacokinetics (PK), efficacy markers, and opioid receptor availability of subcutaneous injections of depot buprenorphine after induction and stabilization of treatment seeking subjects onto Subute...
What is the current status of trial NCT01738503?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2012-10. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01738503?
The interventions under investigation include: RBP-6000 (DRUG), Subutex (DRUG).
Who is sponsoring clinical trial NCT01738503?
This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.
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