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Evaluating the SUBLOCADE Treatment Exit Strategy

Evaluating the SUBLOCADE Treatment Exit Strategy

Non Recruiting
18 years and older
All
Phase N/A

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Overview

The purpose of this study is to observe and assess the successful taper and opioid withdrawal experience after participants stop receiving SUBLOCADE because their healthcare provider determines their disease symptoms have been controlled for at least 9 months and they, together with their healthcare provider, plan to discontinue MOUD.

Description

This is a Phase IV, observational, multicentre, open-label, study in participants with a history of OUD, who have been on SUBLOCADE treatment for at least 12 injections, have had disease symptoms controlled for at least 9 months in the opinion of the healthcare provider, and both healthcare provider and participant plan to discontinue MOUD treatment.

Eligibility

Inclusion Criteria

Participants must meet all of the following criteria:

  • The participant, together with their healthcare provider (the investigator), have previously determined that it is appropriate to stop MOUD treatment, and the participant meets the following criteria:
    • Has been treated with at least 12 injections of SUBLOCADE.
    • In the opinion of the investigator, has had their OUD symptoms (ie, overdose, illicit/nonmedical use, withdrawal) controlled for at least 9 months.
    • In the opinion of the investigator, has had any other substance use disorder (excluding alcohol, nicotine, or cannabis) symptoms controlled for at least 9 months.
  • Is willing to complete the Baseline Visit 4 to 8 weeks after the last dose of

    SUBLOCADE.

  • Has signed the ICF and is 18 years of age or older.
  • Is not currently using opioids to treat a diagnosis other than OUD.

Study details
    Opioid Use Disorder

NCT05878210

Indivior Inc.

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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