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CompletedPhase 4

SUBLOCADE Long-term Outcomes

Key facts

Who runs it
Indivior Inc.
Where
Amherst, Baltimore, Binghamton, Charleston, Charlotte, Clinton, Columbia, Corvallis, Costa Mesa, Dearborn, Dearborn Heights, Decatur, Detroit, Escondido, Fair Haven, Grand Rapids, Greenville, Hialeah, Hollywood, Houston, Kansas City, Miami, Narberth, New York, North New Hyde Park, Oklahoma City, Prairie Village, Richmond, Rockville Centre, Scarborough, Springfield, St Louis, Tupelo, and Westport, United StatesSee the 35 sitesAlso in 3 other countries, 14 sites
Status
Completed
Phase
Phase 4
People taking part
480 people enrolled
Started
31 Aug 2023
Ended
31 Aug 2025
Type of study
Observational
Record updated
5 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • 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

Where in United States

Also in 3 other countries, 14 sites

  • Dent Neurologic InstituteAmherst, United States
  • Maryland Treatment CentersBaltimore, United States
  • United Health ServicesBinghamton, United States
  • Charleston Pain and Rehabilitation CenterCharleston, United States
  • Onsite Clinical Solutions, LLCCharlotte, United States
  • Alpine Research OrganizationClinton, United States
  • Midlands NeurologyColumbia, United States
  • Healing Comfort Clinic, LLCCorvallis, United States
  • ATP Clinical ResearchCosta Mesa, United States
  • THRYV Clinical StudiesDearborn, United States
  • Vida Clinical StudiesDearborn Heights, United States
  • Atlanta VA Medical CenterDecatur, United States
  • Wayne State University HospitalDetroit, United States
  • Neighborhood Healthcare Institute of HealthEscondido, United States
  • North Point Medical CenterFair Haven, United States
  • SHMG Center for Integrative MedicineGrand Rapids, United States
  • Prisma HealthGreenville, United States
  • United Research InstituteHialeah, United States
  • Zenith Clinical Research LLCHollywood, United States
  • Biopharma Informatic, Inc. Research CenterHouston, United States
  • University of Kansas Medical CenterKansas City, United States
  • G+C Research GroupMiami, United States
  • Jackson Health Community CenterMiami, United States
  • Thalia Medical CentreNarberth, United States
  • Icahn School of Medicine at Mount SinaiNew York, United States
  • Core Clinical TrialsNorth New Hyde Park, United States
  • Pahl Pharmaceutical Professionals LlcOklahoma City, United States
  • Collective Medical ResearchPrairie Village, United States
  • Virginia Commonwealth UniversityRichmond, United States
  • Stuart Wasser PracticeRockville Centre, United States
  • Maine HealthScarborough, United States
  • Baystate HealthSpringfield, United States
  • Psych Care ConsultantsSt Louis, United States
  • North Mississippi Medical CenterTupelo, United States
  • Elevate Health and WellnessWestport, United States

About the trial

What the trial wants to find out

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.

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase IV Longitudinal Study of SUBLOCADE (SUBUTEX Prolonged Release) Clinical Outcomes in Adults With Opioid Use Disorder (Opioid Dependence)
Record updated
5 November 2026