Opioid Use Disorder
Conditions
Keywords
Medicine for Opioid Use Disorder (MOUD)
Brief summary
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
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.
Interventions
None listed
Sponsors
Indivior Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | up to a maximum of 4 years | * 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Among those starting SUBLOCADE within 3 months of study Baseline, time to achieve early remission for the first time while on initial SUBLOCADE treatment | up to a maximum of 4 years | DSM-5-Related |
| Participants achieving DSM-5 sustained remission (yes/no) by 1, 1.5, 2, 2.5, and 3 years while on initial SUBLOCADE treatment | up to a maximum of 4 years | DSM-5-Related |
| Time to achieve sustained remission for the first time while on initial SUBLOCADE treatment | up to a maximum of 4 years | DSM-5-Related |
| 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 | up to a maximum of 4 years | MOUD Use and Retention |
| 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 | up to a maximum of 4 years | DSM-5-Related |
| The overall treatment duration for participants who stop initial SUBLOCADE treatment as the result of resolution of OUD symptoms | up to a maximum of 4 years | MOUD Use and Retention |
| 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 | up to a maximum of 4 years | Illicit Opioid Use (Self-Reports) |
| 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 | up to a maximum of 4 years | Opioid Overdose Requiring Intervention |
| Participants switching from initial SUBLOCADE treatment to another MOUD (yes/no), and the corresponding reasons, eg, safety concerns, treatment failure, seeking alternative MOUD treatment | up to a maximum of 4 years | MOUD Use and Retention |
Countries
Australia, Canada, Sweden, United States
Outcome results
None listed