CompletedNot Applicable

SUBLOCADE Long-term Outcomes

United States480 participantsStarted 2023-08-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Participants achieving DSM-5 remission, early or sustained, (yes/no) while on initial SUBLOCADE treatment by 6 months and 1, 1.5, 2, 2.5, and 3 years from study Baseline

Timeframe: up to a maximum of 4 years

Trial details

NCT IDNCT05860959

SponsorIndivior Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-08-31

View on ClinicalTrials.gov More Opioid Use Disorder trials