SUBLOCADE Long-term Outcomes

Indivior

Status: Enrolling

Conditions: Opioid Use Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT05860959

INDV-6000-406

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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