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

Opioid Use Disorder Clinical Trial

Official title:
A Phase II Double Blind, Placebo Controlled, Randomised, Dose-Ranging Study to Assess the Safety and Efficacy of INDV-2000 Over 3 Months in Treatment Seeking Individuals With Opioid Use Disorder

Clinical Trial 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.

Clinical Trial Description

From Day 1 to Day 7, TM buprenorphine and randomized INDV-2000/Placebo will be administered, INDV-2000/Placebo will be administered alone from Day 8 onward. The randomized treatment period starts when the participant receives randomized treatment (at Day 1) and ends at his/her last study visit, if on INDV-2000/Placebo alone, or ends when starting buprenorphine rescue therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06384157
Study type Interventional
Source Indivior Inc.
Contact Global Director Clinical Development
Phone (804) 594-4488
Email trialdisclosure@indivior.com
Status Recruiting
Phase Phase 2
Start date June 10, 2024
Completion date September 2025
View Details
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