NCT05062577

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 \[EOT\]).

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	ASP8062	oral
DRUG	Placebo ASP8062	oral
DRUG	buprenorphine/naloxone	sublingual

Timeline

• Start date: 2021-11-08
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2021-09-30
• Last updated: 2024-11-06

Regulatory

• FDA-regulated drug study