SUBLOCADE Long-term Outcomes

NCT05860959 | Completed

• 1 other identifier: INDV-6000-406
• Study Type: observational
• Target: 480
• Locations: 4 countries
• Sites: 49

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.

Conditions

Opioid Use Disorder

Keywords

Medicine for Opioid Use Disorder (MOUD)

Outcome Measures

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

  * 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 Outcomes (9)

• 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

• 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

• 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

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

  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

  up to a maximum of 4 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (49)

ATP Clinical Research

Costa Mesa, California, 92626, United States

Location

Neighborhood Healthcare-Institute of Health

Escondido, California, 92025, United States

Location

Elevate Health and Wellness

Westport, Connecticut, 06880, United States

Location

United Research Institute

Hialeah, Florida, 33012, United States

Location

Zenith Clinical Research LLC

Hollywood, Florida, 33021, United States

Location

Jackson Health Community Center

Miami, Florida, 33126, United States

Location

G+C Research Group

Miami, Florida, 33134, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033-4004, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Collective Medical Research.

Prairie Village, Kansas, 66210, United States

Location

Maine Health

Scarborough, Maine, 04074-7163, United States

Location

Maryland Treatment Centers

Baltimore, Maryland, 21229, United States

Location

Baystate Health

Springfield, Massachusetts, 01199, United States

Location

THRYV Clinical Studies

Dearborn, Michigan, 48124, United States

Location

Vida Clinical Studies

Dearborn Heights, Michigan, 48127, United States

Location

Wayne State University Hospital

Detroit, Michigan, 48201, United States

Location

North Point Medical Center

Fair Haven, Michigan, 48023, United States

Location

SHMG Center for Integrative Medicine

Grand Rapids, Michigan, 49503-4224, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Psych Care Consultants

St Louis, Missouri, 63141-8704, United States

Location

DENT Neurologic Institute

Amherst, New York, 14226, United States

Location

United Health Services

Binghamton, New York, 13903, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Core Clinical Trials

North New Hyde Park, New York, 11042, United States

Location

Stuart Wasser Practice

Rockville Centre, New York, 11570, United States

Location

Onsite Clinical Solutions LLC

Charlotte, North Carolina, 28277, United States

Location

Pahl Pharmaceutical Professionals LLC

Oklahoma City, Oklahoma, 73112, United States

Location

Healing Comfort Clinic, LLC

Corvallis, Oregon, 97330, United States

Location

Thalia Medical Centre

Narberth, Pennsylvania, 19072, United States

Location

Charleston Pain and Rehabilitation Center

Charleston, South Carolina, 29407, United States

Location

Midlands Neurology

Columbia, South Carolina, 29205, United States

Location

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Biopharma Informatic, Inc. Research Center

Houston, Texas, 77043, United States

Location

Alpine Research Organization

Clinton, Utah, 84015, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

St Vincent's Hospital Melbourne

Fitzroy, Melbourne, 3065, Australia

Location

John Hunter Hospital

Newcastle, New South Wales, 2300, Australia

Location

Drug and Alcohol Services South Australia (DASSA)

Stepney, South Australia, 5069, Australia

Location

Turning Point

Richmond, VIC 3121, Australia

Location

Smart Clinic

Calgary, Alberta, T2E2R2, Canada

Location

Recovery Alberta

Edmonton, Alberta, T5J 3E4, Canada

Location

Fraser Health Authority

Surrey, British Columbia, V3T 0H1, Canada

Location

Dr. J.S. Dhillon Medicine Prof. Corp

Burlington, Ontario, L7M 4X9, Canada

Location

The Stipley Clinic

Hamilton, Ontario, L8N 1H3, Canada

Location

Brightshores Health System

Owen Sound, Ontario, N4K 6M9, Canada

Location

Bluewater Rapid Assessment Addiction Medicine Clinic

Sarnia, Ontario, N7T 5W9, Canada

Location

Comprehensive Treatment Clinic

Toronto, Ontario, M4J 1M3, Canada

Location

Linkoping University Hospital, Psychiatry Center

Linköping, 58185, Sweden

Location

Beroendecentrum

Stockholm, SE-11365, Sweden

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 16, 2023
• Study Start: August 31, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: October 16, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4); US (35); SE (2); CA (8)