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OpenTrials
Completed

NCT Number: NCT05860959

SUBLOCADE Long-term Outcomes

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Vincent's Hospital Melbourne, Fitzroy, Melbourne, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. 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

    Time frame: up to a maximum of 4 years

    DSM-5-Related

  2. Among those starting SUBLOCADE within 3 months of study Baseline, time to achieve early remission for the first time while on initial SUBLOCADE treatment

    Time frame: up to a maximum of 4 years

    DSM-5-Related

  3. Participants achieving DSM-5 sustained remission (yes/no) by 1, 1.5, 2, 2.5, and 3 years while on initial SUBLOCADE treatment

    Time frame: up to a maximum of 4 years

    DSM-5-Related

  4. Time to achieve sustained remission for the first time while on initial SUBLOCADE treatment

    Time frame: up to a maximum of 4 years

    DSM-5-Related

  5. 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

    Time frame: up to a maximum of 4 years

    MOUD Use and Retention

  6. Participants switching from initial SUBLOCADE treatment to another MOUD (yes/no), and the corresponding reasons, eg, safety concerns, treatment failure, seeking alternative MOUD treatment

    Time frame: up to a maximum of 4 years

    MOUD Use and Retention

  7. The overall treatment duration for participants who stop initial SUBLOCADE treatment as the result of resolution of OUD symptoms

    Time frame: up to a maximum of 4 years

    MOUD Use and Retention

  8. 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

    Time frame: up to a maximum of 4 years

    Illicit Opioid Use (Self-Reports)

  9. 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

    Time frame: up to a maximum of 4 years

    Opioid Overdose Requiring Intervention

Sponsors and collaborators

Lead sponsor

Indivior Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 16, 2023
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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