NCT05860959

SUBLOCADE Long-term Outcomes

A Phase IV Longitudinal Study of SUBLOCADE (SUBUTEX Prolonged Release) Clinical Outcomes in Adults With Opioid Use Disorder (Opioid Dependence)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 480 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will provide the opportunity to generate data on the long-term use of SUBLOCADE under real-world conditions, and to observe enduring changes in lifestyle, health, and sociodemographic factors that are part of the recovery process. Long-term patterns of abstinence/opioid misuse as well as measures of participants' physical, psychological, social, and economic well-being will be monitored to better understand factors associated with recovery from opioid use disorder (OUD). Therefore, this study will observe participants up to a maximum of 4 years.

Detailed description

This is a Phase IV, prospective, multicentre, multinational, open-label, real-world observational study in participants with current or a history of OUD/opioid dependence.

Conditions

• Opioid Use Disorder

Timeline

• Start date: 2023-08-31
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2023-05-16
• Last updated: 2025-10-16

Locations

49 sites across 4 countries: United States, Australia, Canada, Sweden