SUBLOCADE Long-term Outcomes

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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use Disorder

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 Type: Observational
• Enrollment (Actual): 480

Contacts and Locations

Study Locations

• Australia
  • Richmond, Australia, VIC 3121
    • Turning Point
  • Melbourne
    • Fitzroy, Melbourne, Australia, 3065
      • St Vincent's Hospital Melbourne
  • New South Wales
    • Newcastle, New South Wales, Australia, 2300
      • John Hunter Hospital
  • South Australia
    • Stepney, South Australia, Australia, 5069
      • Drug and Alcohol Services South Australia (DASSA)
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2E2R2
      • Smart Clinic
    • Edmonton, Alberta, Canada, T5J 3E4
      • Recovery Alberta
  • British Columbia
    • Surrey, British Columbia, Canada, V3T 0H1
      • Fraser Health Authority
  • Ontario
    • Burlington, Ontario, Canada, L7M 4X9
      • Dr. J.S. Dhillon Medicine Prof. Corp
    • Hamilton, Ontario, Canada, L8N 1H3
      • The Stipley Clinic
    • Owen Sound, Ontario, Canada, N4K 6M9
      • Brightshores Health System
    • Sarnia, Ontario, Canada, N7T 5W9
      • Bluewater Rapid Assessment Addiction Medicine Clinic
    • Toronto, Ontario, Canada, M4J 1M3
      • Comprehensive Treatment Clinic
• Sweden
  • Linköping, Sweden, 58185
    • Linkoping University Hospital, Psychiatry Center
  • Stockholm, Sweden, SE-11365
    • Beroendecentrum
• United States
  • California
    • Costa Mesa, California, United States, 92626
      • ATP Clinical Research
    • Escondido, California, United States, 92025
      • Neighborhood Healthcare-Institute of Health
  • Connecticut
    • Westport, Connecticut, United States, 06880
      • Elevate Health and Wellness
  • Florida
    • Hialeah, Florida, United States, 33012
      • United Research Institute
    • Hollywood, Florida, United States, 33021
      • Zenith Clinical Research LLC
    • Miami, Florida, United States, 33126
      • Jackson Health Community Center
    • Miami, Florida, United States, 33134
      • G+C Research Group
  • Georgia
    • Decatur, Georgia, United States, 30033-4004
      • Atlanta VA Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
    • Prairie Village, Kansas, United States, 66210
      • Collective Medical Research.
  • Maine
    • Scarborough, Maine, United States, 04074-7163
      • Maine Health
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Maryland Treatment Centers
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Health
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • THRYV Clinical Studies
    • Dearborn Heights, Michigan, United States, 48127
      • Vida Clinical Studies
    • Detroit, Michigan, United States, 48201
      • Wayne State University Hospital
    • Fair Haven, Michigan, United States, 48023
      • North Point Medical Center
    • Grand Rapids, Michigan, United States, 49503-4224
      • SHMG Center for Integrative Medicine
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • Missouri
    • St Louis, Missouri, United States, 63141-8704
      • Psych Care Consultants
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurologic Institute
    • Binghamton, New York, United States, 13903
      • United Health Services
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • North New Hyde Park, New York, United States, 11042
      • Core Clinical Trials
    • Rockville Centre, New York, United States, 11570
      • Stuart Wasser Practice
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • OnSite Clinical Solutions LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Pahl Pharmaceutical Professionals Llc
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • Healing Comfort Clinic, LLC
  • Pennsylvania
    • Narberth, Pennsylvania, United States, 19072
      • Thalia Medical Centre
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Charleston Pain and Rehabilitation Center
    • Columbia, South Carolina, United States, 29205
      • Midlands Neurology
    • Greenville, South Carolina, United States, 29605
      • Prisma Health
  • Texas
    • Houston, Texas, United States, 77043
      • Biopharma Informatic, Inc. Research Center
  • Utah
    • Clinton, Utah, United States, 84015
      • Alpine Research Organization
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants may enroll if they have initiated treatment with SUBLOCADE within 3 months prior to signing the informed consent form (ICF), or have completed an Indivior SUBLOCADE study (eg, INDV-6000-401, INDV-6000-405) and received their last dose of SUBLOCADE on the study within 3 months prior to signing the ICF, and plan to receive additional SUBLOCADE injections.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indivior Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Estimated): October 16, 2025
• Last Update Submitted That Met QC Criteria: October 14, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Medicine for Opioid Use Disorder (MOUD)
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: INDV-6000-406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No