Evaluating the SUBLOCADE Treatment Exit Strategy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-24

Study Completion Date

2025-05-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Opioid Use Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No