drugset / Trial / NCT06384157

Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder

NCT06384157

Phase 2 Completed 300 enrolled Indivior Inc.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2024-06-10
Primary completion
2025-09-29
Completion
2025-11-03

Drugs

EvaluationDrugModalityDoseRoute
Subject INDV-2000 Unknown 100 mg
Subject INDV-2000 Unknown 200 mg
Subject INDV-2000 Unknown 400 mg