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SUBLOCADE Long-term Outcomes

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

Inclusion Criteria:

Participants must meet all of the following criteria:

  • Is an adult ≥ 18 years of age who has signed the informed consent form
  • Plans to receive additional SUBLOCADE injections and
    • Has initiated treatment for OUD/opioid dependence with SUBLOCADE within the last 3 months prior to Baseline Visit
      • OR
    • Has completed an Indivior SUBLOCADE study (eg, INDV-6000-401, INDV-6000-405)

      and has received the last dose of SUBLOCADE on that study within 3 months prior to Baseline Visit

  • Is not currently participating in any clinical trial requiring medical intervention
  • Is not currently using opioids to treat a diagnosis other than OUD/opioid dependence

Study details

Opioid Use Disorder

NCT05860959

Indivior Inc.

11 April 2025

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