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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 is a Phase 3 study that has completed, run by Indivior. The registered enrollment target is 775 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02510014
The ClinicalTrials.gov registry entry for NCT02510014 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 775 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.
NCT02510014 reports 0 study locations.
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.
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