SUBLOCADE Long-term Outcomes

NCT ID: NCT05860959

Last Updated: 2025-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-31

Study Completion Date

2025-08-31

Brief Summary

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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

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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.

Conditions

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Opioid Use Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indivior Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ATP Clinical Research

Costa Mesa, California, United States

Site Status

Neighborhood Healthcare-Institute of Health

Escondido, California, United States

Site Status

Elevate Health and Wellness

Westport, Connecticut, United States

Site Status

United Research Institute

Hialeah, Florida, United States

Site Status

Zenith Clinical Research LLC

Hollywood, Florida, United States

Site Status

Jackson Health Community Center

Miami, Florida, United States

Site Status

G+C Research Group

Miami, Florida, United States

Site Status

Atlanta VA Medical Center

Decatur, Georgia, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Collective Medical Research.

Prairie Village, Kansas, United States

Site Status

Maine Health

Scarborough, Maine, United States

Site Status

Maryland Treatment Centers

Baltimore, Maryland, United States

Site Status

Baystate Health

Springfield, Massachusetts, United States

Site Status

THRYV Clinical Studies

Dearborn, Michigan, United States

Site Status

Vida Clinical Studies

Dearborn Heights, Michigan, United States

Site Status

Wayne State University Hospital

Detroit, Michigan, United States

Site Status

North Point Medical Center

Fair Haven, Michigan, United States

Site Status

SHMG Center for Integrative Medicine

Grand Rapids, Michigan, United States

Site Status

North Mississippi Medical Center

Tupelo, Mississippi, United States

Site Status

Psych Care Consultants

St Louis, Missouri, United States

Site Status

DENT Neurologic Institute

Amherst, New York, United States

Site Status

United Health Services

Binghamton, New York, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Core Clinical Trials

North New Hyde Park, New York, United States

Site Status

Stuart Wasser Practice

Rockville Centre, New York, United States

Site Status

Onsite Clinical Solutions LLC

Charlotte, North Carolina, United States

Site Status

Pahl Pharmaceutical Professionals LLC

Oklahoma City, Oklahoma, United States

Site Status

Healing Comfort Clinic, LLC

Corvallis, Oregon, United States

Site Status

Thalia Medical Centre

Narberth, Pennsylvania, United States

Site Status

Charleston Pain and Rehabilitation Center

Charleston, South Carolina, United States

Site Status

Midlands Neurology

Columbia, South Carolina, United States

Site Status

Prisma Health

Greenville, South Carolina, United States

Site Status

Biopharma Informatic, Inc. Research Center

Houston, Texas, United States

Site Status

Alpine Research Organization

Clinton, Utah, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

St Vincent's Hospital Melbourne

Fitzroy, Melbourne, Australia

Site Status

John Hunter Hospital

Newcastle, New South Wales, Australia

Site Status

Drug and Alcohol Services South Australia (DASSA)

Stepney, South Australia, Australia

Site Status

Turning Point

Richmond, , Australia

Site Status

Smart Clinic

Calgary, Alberta, Canada

Site Status

Recovery Alberta

Edmonton, Alberta, Canada

Site Status

Fraser Health Authority

Surrey, British Columbia, Canada

Site Status

Dr. J.S. Dhillon Medicine Prof. Corp

Burlington, Ontario, Canada

Site Status

The Stipley Clinic

Hamilton, Ontario, Canada

Site Status

Brightshores Health System

Owen Sound, Ontario, Canada

Site Status

Bluewater Rapid Assessment Addiction Medicine Clinic

Sarnia, Ontario, Canada

Site Status

Comprehensive Treatment Clinic

Toronto, Ontario, Canada

Site Status

Linkoping University Hospital, Psychiatry Center

Linköping, , Sweden

Site Status

Beroendecentrum

Stockholm, , Sweden

Site Status

Countries

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United States Australia Canada Sweden

Other Identifiers

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INDV-6000-406

Identifier Type: -

Identifier Source: org_study_id

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