NCT06384157

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	INDV-2000	INDV-2000 is a highly potent and selective OX1R antagonist that is being developed as a therapy for the treatment of OUD.
OTHER	Placebo	This is a randomized, double-blind, placebo-controlled study.

Timeline

• Start date: 2024-06-10
• Primary completion: 2025-09-29
• Completion: 2025-11-03
• First posted: 2024-04-25
• Last updated: 2025-12-16

Locations

35 sites across 1 country: United States

Regulatory

• FDA-regulated drug study