SUBLOCADE Long-term Outcomes

Active, not recruiting

• Conditions: Opioid Use Disorder

• Registration Number: NCT05860959
• Lead Sponsor: Indivior Inc.

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.

Study Timeline

• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-16
• Study Start: 2023-08-31
• Status Verified: 2024-12
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-04
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1200

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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)
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
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
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
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
Time to achieve sustained remission for the first time while on initial SUBLOCADE treatment	up to a maximum of 4 years	DSM-5-Related
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

Trial Locations

Locations (49)

ATP Clinical Research; 🇺🇸 Costa Mesa, California, United States

Neighborhood Healthcare-Institute of Health; 🇺🇸 Escondido, California, United States

Elevate Health and Wellness; 🇺🇸 Westport, Connecticut, United States

United Research Institute; 🇺🇸 Hialeah, Florida, United States

Zenith Clinical Research LLC; 🇺🇸 Hollywood, Florida, United States

Jackson Health Community Center; 🇺🇸 Miami, Florida, United States

G+C Research Group; 🇺🇸 Miami, Florida, United States

Atlanta VA Medical Center; 🇺🇸 Decatur, Georgia, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Collective Medical Research.; 🇺🇸 Prairie Village, Kansas, United States

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