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A Study to Assess the Safety and Efficacy of ASP8062 as an Add-on Therapy to Buprenorphine/Naloxone in Participants With Opioid Use Disorder

Opioid Use Disorder Clinical Trial

Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ASP8062 as an Add-on Therapy to Buprenorphine/Naloxone in Participants With Opioid Use Disorder

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy; safety and tolerability of ASP8062 compared with placebo ASP8062 as add-on therapy to buprenorphine/naloxone.

Clinical Trial Description

The study will consist of the following periods: Screening Period (up to 56 days); Double-blind treatment period (12 weeks/ 85 days); a Buprenorphine/naloxone down-titration period (as determined by the participant in collaboration with the investigator) (14 days); and a Follow-up period (30 days post last dose ASP8062 or placebo ASP8062 for ASP8062 End of Treatment [EOT]). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05062577
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Withdrawn
Phase Phase 2
Start date November 8, 2021
Completion date February 28, 2023
View Details
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