MedPath

SUBLOCADE Long-term Outcomes

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
1200
Inclusion Criteria

Participants must meet all of the following criteria:

  • Is an adult โ‰ฅ 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

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Exclusion Criteria

Not provided

Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Baselineup 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
NameTimeMethod
Among those starting SUBLOCADE within 3 months of study Baseline, time to achieve early remission for the first time while on initial SUBLOCADE treatmentup 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 treatmentup 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 treatmentup to a maximum of 4 years

Illicit Opioid Use (Self-Reports)

Key Secondary: Participants with "no symptoms" or improving by โ‰ฅ1 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 3up 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 treatmentup 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 treatmentup 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 symptomsup to a maximum of 4 years

MOUD Use and Retention

Time to achieve sustained remission for the first time while on initial SUBLOCADE treatmentup 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 3up to a maximum of 4 years

Opioid Overdose Requiring Intervention

Trial Locations

Locations (47)

SHMG Center for Integrative Medicine

๐Ÿ‡บ๐Ÿ‡ธ

Grand Rapids, Michigan, United States

North Mississippi Medical Center

๐Ÿ‡บ๐Ÿ‡ธ

Tupelo, Mississippi, United States

United Health Services

๐Ÿ‡บ๐Ÿ‡ธ

Binghamton, New York, United States

Charleston Pain and Rehabilitation Center

๐Ÿ‡บ๐Ÿ‡ธ

Charleston, South Carolina, United States

Biopharma Informatic, Inc. Research Center

๐Ÿ‡บ๐Ÿ‡ธ

Houston, Texas, United States

John Hunter Hospital

๐Ÿ‡ฆ๐Ÿ‡บ

Newcastle, New South Wales, Australia

Smart Clinic

๐Ÿ‡จ๐Ÿ‡ฆ

Calgary, Alberta, Canada

The Stipley Clinic

๐Ÿ‡จ๐Ÿ‡ฆ

Hamilton, Ontario, Canada

Beroendecentrum

๐Ÿ‡ธ๐Ÿ‡ช

Stockholm, Sweden

ATP Clinical Research

๐Ÿ‡บ๐Ÿ‡ธ

Costa Mesa, California, United States

Neighborhood Healthcare-Institute of Health

๐Ÿ‡บ๐Ÿ‡ธ

Escondido, California, United States

Elevate Health and Wellness

๐Ÿ‡บ๐Ÿ‡ธ

Westport, Connecticut, United States

United Research Institute

๐Ÿ‡บ๐Ÿ‡ธ

Hialeah, Florida, United States

Zenith Clinical Research LLC

๐Ÿ‡บ๐Ÿ‡ธ

Hollywood, Florida, United States

Jackson Health Community Center

๐Ÿ‡บ๐Ÿ‡ธ

Miami, Florida, United States

G+C Research Group

๐Ÿ‡บ๐Ÿ‡ธ

Miami, Florida, United States

Innovation Clinical 8 St. Inc.

๐Ÿ‡บ๐Ÿ‡ธ

Miami, Florida, United States

Innovation Clinical Trials, Inc.

๐Ÿ‡บ๐Ÿ‡ธ

Palmetto Bay, Florida, United States

Atlanta VA Medical Center

๐Ÿ‡บ๐Ÿ‡ธ

Decatur, Georgia, United States

University of Kansas Medical Center

๐Ÿ‡บ๐Ÿ‡ธ

Kansas City, Kansas, United States

Collective Medical Research.

๐Ÿ‡บ๐Ÿ‡ธ

Prairie Village, Kansas, United States

Maine Health

๐Ÿ‡บ๐Ÿ‡ธ

Scarborough, Maine, United States

Maryland Treatment Centers

๐Ÿ‡บ๐Ÿ‡ธ

Baltimore, Maryland, United States

Baystate Health

๐Ÿ‡บ๐Ÿ‡ธ

Springfield, Massachusetts, United States

Vida Clinical Studies

๐Ÿ‡บ๐Ÿ‡ธ

Dearborn Heights, Michigan, United States

THRYV Clinical Studies

๐Ÿ‡บ๐Ÿ‡ธ

Dearborn, Michigan, United States

North Point Medical Center

๐Ÿ‡บ๐Ÿ‡ธ

Fair Haven, Michigan, United States

Psych Care Consultants

๐Ÿ‡บ๐Ÿ‡ธ

Saint Louis, Missouri, United States

DENT Neurologic Institute

๐Ÿ‡บ๐Ÿ‡ธ

Amherst, New York, United States

Icahn School of Medicine at Mount Sinai

๐Ÿ‡บ๐Ÿ‡ธ

New York, New York, United States

Core Clinical Trials

๐Ÿ‡บ๐Ÿ‡ธ

North New Hyde Park, New York, United States

Stuart Wasser Practice

๐Ÿ‡บ๐Ÿ‡ธ

Rockville Centre, New York, United States

Onsite Clinical Solutions LLC

๐Ÿ‡บ๐Ÿ‡ธ

Charlotte, North Carolina, United States

Pahl Pharmaceutical Professionals LLC

๐Ÿ‡บ๐Ÿ‡ธ

Oklahoma City, Oklahoma, United States

VAST Clinical Research

๐Ÿ‡บ๐Ÿ‡ธ

Sulphur, Oklahoma, United States

Healing Comfort Clinic, LLC

๐Ÿ‡บ๐Ÿ‡ธ

Corvallis, Oregon, United States

Thalia Medical Centre

๐Ÿ‡บ๐Ÿ‡ธ

Narberth, Pennsylvania, United States

Midlands Neurology

๐Ÿ‡บ๐Ÿ‡ธ

Columbia, South Carolina, United States

Prisma Health

๐Ÿ‡บ๐Ÿ‡ธ

Greenville, South Carolina, United States

Alpine Research Organization

๐Ÿ‡บ๐Ÿ‡ธ

Clinton, Utah, United States

Drug and Alcohol Services South Australia (DASSA)

๐Ÿ‡ฆ๐Ÿ‡บ

Stepney, South Australia, Australia

Eastern Health

๐Ÿ‡ฆ๐Ÿ‡บ

Richmond, Australia

Savera Medical Centre

๐Ÿ‡จ๐Ÿ‡ฆ

Edmonton, Ontario, Canada

Brightshores Health System

๐Ÿ‡จ๐Ÿ‡ฆ

Owen Sound, Ontario, Canada

Bluewater Rapid Assessment Addiction Medicine Clinic

๐Ÿ‡จ๐Ÿ‡ฆ

Sarnia, Ontario, Canada

Comprehensive Treatment Clinic

๐Ÿ‡จ๐Ÿ‡ฆ

Toronto, Ontario, Canada

Linkoping University Hospital, Psychiatry Center

๐Ÿ‡ธ๐Ÿ‡ช

Linkรถping, Sweden

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