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NCT04995029 · ClinicalTrials.gov registry record · Phase 4
Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users
A Phase 4 study, sponsored by Indivior.
- Completed
- Registry status
- Phase 4
- Development phase
- 785
- Enrollment target
NCT04995029: Completed Phase 4 study, sponsored by Indivior.
NCT04995029 is a Phase 4 study that has completed, run by Indivior. The registered enrollment target is 785 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (52% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04995029, a Phase 4 study, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 785 participants
- Enrollment target
Study Summary
The primary objective of the induction phase of the study is to compare treatment retention of participants following rapid induction or standard of care (SoC) induction onto extended-release buprenorphine. The primary objective of the maintenance phase is to compare the efficacy of 100 mg and 300 mg maintenance doses of extended-release buprenorphine administered every 4 weeks.
Primary Outcome
A responder for weekly opioid use is defined as a participant whose percentage of visits with opioid abstinence is greater than or equal to 80% over Weeks 20 to 38 inclusive. Opioid abstinence is defined as a negative urine drug screen (UDS) result and negative responses to the TimeLine Follow Back (TLFB) interview for opioid use. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit.
Interventions
- DRUG Extended-release Buprenorphine
- DRUG Transmucosal Buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 785 participants |
| Start Date | 2021-10-26 |
| Est. Completion | 2024-06-26 |
| Phase | Phase 4 |
What the finished NCT04995029 record still lists
NCT04995029 is an interventional study that assigns participants to a tested intervention. The registered 785 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (52% higher).
The record links to 0 conditions, and to 2 interventions - of which Extended-release Buprenorphine is the first listed.
NCT04995029 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04995029 about?
NCT04995029 is a clinical study titled "Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users". The primary objective of the induction phase of the study is to compare treatment retention of participants following rapid induction or standard of care (SoC) induction onto extended-release buprenorphine. The primary objective of the maintenance phase is to compare the efficacy of 100 mg and 300 ...
What is the current status of trial NCT04995029?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 785 participants. The study started on 2021-10-26. Estimated completion is 2024-06-26.
What interventions are being tested in trial NCT04995029?
The interventions under investigation include: Extended-release Buprenorphine (DRUG), Transmucosal Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT04995029?
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 NCT04995029's enrollment target sits among peer trials
785 103rd of 2000 higher than 1,898 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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