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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: Completed Phase 2 study, sponsored by Indivior.
NCT01738503 is a Phase 2 study that has completed, run by Indivior. The registered enrollment target is 124 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalizati
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 |
What the finished NCT01738503 record still lists
NCT01738503 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which RBP-6000 is the first listed.
NCT01738503 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01738503's enrollment target sits among peer trials
124 564th of 2000 higher than 1,437 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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