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NCT06384157 · ClinicalTrials.gov registry record · Phase 2
Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder
A Phase 2 study, sponsored by Indivior.
- Completed
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
NCT06384157: Completed Phase 2 study, sponsored by Indivior.
NCT06384157 is a Phase 2 study that has completed, run by Indivior. The registered enrollment target is 300 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06384157, a Phase 2 study, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
Study Summary
The purpose of this study is to measure safety and efficacy and to determine dose-response relationship for INDV-2000 in participants with moderate to severe Opioid Use Disorder (OUD) who are new to treatment, have recently initiated or completed short-term medically supervised withdrawal with transmucosal (TM) buprenorphine, and are interested in transitioning to a non opioid treatment.
Primary Outcome
The treatment failure is defined as meeting either one of the two criteria. 1. Urine Drug Screen (UDS, dipstick) positive for opioids, or fentanyl on 4 consecutive assessments while participants on the Investigational Medicinal Product (IMP) (INDV-2000 or placebo) alone (after Day 8 visit). 2. Discontinued the IMP (INDV-2000 or placebo) prematurely.
Interventions
- OTHER Placebo
- DRUG INDV-2000
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2024-06-10 |
| Est. Completion | 2025-11-03 |
| Phase | Phase 2 |
What the finished NCT06384157 record still lists
NCT06384157 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06384157 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06384157 about?
NCT06384157 is a clinical study titled "Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder". The purpose of this study is to measure safety and efficacy and to determine dose-response relationship for INDV-2000 in participants with moderate to severe Opioid Use Disorder (OUD) who are new to treatment, have recently initiated or completed short-term medically supervised withdrawal with trans...
What is the current status of trial NCT06384157?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2024-06-10. Estimated completion is 2025-11-03.
What interventions are being tested in trial NCT06384157?
The interventions under investigation include: Placebo (OTHER), INDV-2000 (DRUG).
Who is sponsoring clinical trial NCT06384157?
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 NCT06384157's enrollment target sits among peer trials
300 167th of 2000 higher than 1,813 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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