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Long-term outcomes of SUBLOCADE for opioid use disorder

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

Observational Indivior Inc. · NCT05860959

This study looks at how well SUBLOCADE helps adults with opioid use disorder over the long term by tracking their recovery and overall well-being for up to four years.

Quick facts

Study typeObservational
Enrollment1200 (estimated)
Ages18 Years and up
SexAll
SponsorIndivior Inc. Industry-sponsored
Locations53 sites (Costa Mesa, California and 52 other locations)
Trial IDNCT05860959 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather data on the long-term effects of SUBLOCADE in treating opioid use disorder (OUD) in real-world settings. Participants will be monitored for up to four years to assess changes in their lifestyle, health, and social factors associated with recovery. The study will track patterns of abstinence and opioid misuse, as well as various measures of participants' physical, psychological, social, and economic well-being. This multicenter, multinational study will include adults who have recently initiated or completed treatment with SUBLOCADE.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have recently started or completed treatment with SUBLOCADE for opioid dependence.

Not a fit: Patients currently participating in other clinical trials requiring medical intervention or using opioids for conditions other than OUD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of SUBLOCADE, potentially improving treatment strategies for patients with opioid use disorder.

How similar studies have performed: While this study builds on existing knowledge of SUBLOCADE, it focuses on long-term outcomes in a real-world setting, which has not been extensively studied before.

Eligibility criteria

Show full inclusion / 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

Where this trial is running

Costa Mesa, California and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Opioid Use DisorderMedicine for Opioid Use Disorder
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.