SUBLOCADE Long-term Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a Phase IV, prospective, multicentre, multinational, open-label, real-world observational study in participants with current or a history of OUD/opioid dependence.

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

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: 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

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 |
| --- | --- | --- |
| 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 | Definition of early remission: None of the criteria for OUD has been met for at least 3 months but for less than 12 months with the exception that Criterion 4 (Craving, or a strong desire or urge to use opioids,) may be met. Definition of sustained remission: None of the criteria for OUD has been met for at least 12 months with the exception that Criterion 4 (Craving, or a strong desire or urge to use opioids,) may be met. | up to a maximum of 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Key Secondary: Participants with no symptoms or improving by ≥1 DSM-5 severity classification within the last 3 months (moderate to mild, or severe to mild or moderate) relative to study Baseline (yes/no) at Month 6 and Years 1, 2, and 3 | DSM-5-Related | up to a maximum of 4 years | 
| Among those starting SUBLOCADE within 3 months of study Baseline, time to achieve early remission for the first time while on initial SUBLOCADE treatment | DSM-5-Related | up to a maximum of 4 years | 
| Participants achieving DSM-5 sustained remission (yes/no) by 1, 1.5, 2, 2.5, and 3 years while on initial SUBLOCADE treatment | DSM-5-Related | up to a maximum of 4 years | 
| Time to achieve sustained remission for the first time while on initial SUBLOCADE treatment | DSM-5-Related | up to a maximum of 4 years | 
| Time to discontinuing initial SUBLOCADE treatment and the corresponding reasons for discontinuation, eg, resolution of OUD symptoms, safety concerns, treatment failure, or seeking alternative MOUD treatment | MOUD Use and Retention | up to a maximum of 4 years | 
| Participants switching from initial SUBLOCADE treatment to another MOUD (yes/no), and the corresponding reasons, eg, safety concerns, treatment failure, seeking alternative MOUD treatment | MOUD Use and Retention | up to a maximum of 4 years | 
| The overall treatment duration for participants who stop initial SUBLOCADE treatment as the result of resolution of OUD symptoms | MOUD Use and Retention | up to a maximum of 4 years | 
| Participants with any positive opioid use in the past month (yes/no) at Month 6 and Years 1, 2, and 3 while on initial SUBLOCADE treatment | Illicit Opioid Use (Self-Reports) | up to a maximum of 4 years | 
| Participants with opioid overdose requiring intervention (yes/no) while on initial SUBLOCADE treatment at least once during the first 6 months, and during Years 1, 2, and 3 | Opioid Overdose Requiring Intervention | up to a maximum of 4 years | 

 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)