Evaluating the SUBLOCADE Treatment Exit Strategy

Study Overview
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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.

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.

Official Title
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A Phase IV Study to Evaluate the SUBLOCADE Treatment Exit Strategy

Conditions
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Opioid Use Disorder

Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful taper by the end of 6-month follow-up. | Successful taper is defined as no consistent self-reported illicit/nonmedical opioid use and not restarting long-term MOUD treatment due to opioid withdrawal or illicit/nonmedical opioid use during follow up. Consistent self-reported illicit/nonmedical opioid use is defined as self-reported 4 consecutive use weeks (ie, weeks with at least 1 day of illicit/nonmedical opioid use per week) or 7 consecutive days of illicit/nonmedical opioid use. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Key secondary - At each given month, for participants not restarting MOUD and not consistently using illicit/nonmedical opioid up to the start of that month: | Average clinical experience score (range: 0 to 4 with higher score = worse outcome) on opioid withdrawal severity during the past month | 6 months | 
| Participants restarting MOUD (yes/no) during study follow-up | Yes/No | 6 months | 
| Participants who reported withdrawal symptoms (yes/no) during the past month | Yes/No | 6 months | 
| Participants who used ancillary medications to treat opioid withdrawal symptoms (yes/no) during the past month | Yes/No | 6 months | 
| Participants who used rescue MOUD (yes/no) to treat opioid withdrawal symptoms during the past month | Yes/No | 6 months | 
| Participants who had self-reported illicit/nonmedical opioid use (yes/no) during the past month | Yes/No | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medicine for Opioid Use Disorder (MOUD)