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

Study testing INDV-2000 for moderate to severe opioid addiction.

Recruiting
18-65 years
All
Phase 2
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study tests a new treatment, INDV-2000, for people with moderate to severe Opioid Use Disorder (OUD), a condition where people are unable to stop using opioids despite wanting to. Participants should be starting or have recently finished withdrawal with transmucosal (TM) buprenorphine, a medication to help stop opioid use, and want to try a non-opioid treatment. The study lasts for up to 7 days with TM buprenorphine and INDV-2000 or a placebo (a pill with no medicine). After 7 days, only INDV-2000 or placebo is given.

Eligibility: Participants must be between 18-65 years, able to understand study rules, and not have taken opioid medication for 3 months before starting this study. They should not have serious health issues or other substance use problems.

  • Study duration varies per participant but involves multiple visits.
  • Participants are randomly assigned to either receive INDV-2000 or placebo.
  • Safety and effectiveness are closely monitored throughout the study.
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Study details
    Opioid Use Disorder

NCT06384157

Indivior Inc.

7 June 2025

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