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NCT02510014 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder
A Phase 3 study, sponsored by Indivior.
- Completed
- Registry status
- Phase 3
- Development phase
- 775
- Enrollment target
NCT02510014: Completed Phase 3 study, sponsored by Indivior.
NCT02510014 is a Phase 3 study that has completed, run by Indivior. The registered enrollment target is 775 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02510014, a Phase 3 study, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 775 participants
- Enrollment target
Study Summary
A multi-center, open-label, long-term safety study in which approximately 600 subjects diagnosed with opioid use disorder will be enrolled. Following a screening period, all subjects will receive run in SUBOXONE sublingual film followed by an initial injection of open-label high dose (300 mg) RBP-6000. The RBP-6000 monthly injection dose can be adjusted to low dose (100 mg), and back to high dose, based on the medical judgment of the Investigator. Subjects will participate in the study for either 6 or 12 months.
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 SUBOXONE sublingual film
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 775 participants |
| Start Date | 2015-07-27 |
| Est. Completion | 2017-01-31 |
| Phase | Phase 3 |
What the finished NCT02510014 record still lists
NCT02510014 is an interventional study that assigns participants to a tested intervention. The registered 775 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which RBP-6000 is the first listed.
NCT02510014 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02510014 about?
NCT02510014 is a clinical study titled "Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder". A multi-center, open-label, long-term safety study in which approximately 600 subjects diagnosed with opioid use disorder will be enrolled. Following a screening period, all subjects will receive run in SUBOXONE sublingual film followed by an initial injection of open-label high dose (300 mg) RBP-60...
What is the current status of trial NCT02510014?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 775 participants. The study started on 2015-07-27. Estimated completion is 2017-01-31.
What interventions are being tested in trial NCT02510014?
The interventions under investigation include: RBP-6000 (DRUG), SUBOXONE sublingual film (DRUG).
Who is sponsoring clinical trial NCT02510014?
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 NCT02510014's enrollment target sits among peer trials
775 439th of 2000 higher than 1,562 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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