SUBLOCADE Long-term Outcomes
- 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
Participants must meet all of the following criteria:
-
Is an adult โฅ 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 up 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
Name Time Method 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 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 treatment up 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 treatment up to a maximum of 4 years Illicit Opioid Use (Self-Reports)
Key Secondary: Participants with "no symptoms" or improving by โฅ1 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 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 treatment up 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 treatment up 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 symptoms up to a maximum of 4 years MOUD Use and Retention
Time to achieve sustained remission for the first time while on initial SUBLOCADE treatment up 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 3 up to a maximum of 4 years Opioid Overdose Requiring Intervention
Trial Locations
- Locations (47)
SHMG Center for Integrative Medicine
๐บ๐ธGrand Rapids, Michigan, United States
North Mississippi Medical Center
๐บ๐ธTupelo, Mississippi, United States
United Health Services
๐บ๐ธBinghamton, New York, United States
Charleston Pain and Rehabilitation Center
๐บ๐ธCharleston, South Carolina, United States
Biopharma Informatic, Inc. Research Center
๐บ๐ธHouston, Texas, United States
John Hunter Hospital
๐ฆ๐บNewcastle, New South Wales, Australia
Smart Clinic
๐จ๐ฆCalgary, Alberta, Canada
The Stipley Clinic
๐จ๐ฆHamilton, Ontario, Canada
Beroendecentrum
๐ธ๐ชStockholm, Sweden
ATP Clinical Research
๐บ๐ธCosta Mesa, California, United States
Neighborhood Healthcare-Institute of Health
๐บ๐ธEscondido, California, United States
Elevate Health and Wellness
๐บ๐ธWestport, Connecticut, United States
United Research Institute
๐บ๐ธHialeah, Florida, United States
Zenith Clinical Research LLC
๐บ๐ธHollywood, Florida, United States
Jackson Health Community Center
๐บ๐ธMiami, Florida, United States
G+C Research Group
๐บ๐ธMiami, Florida, United States
Innovation Clinical 8 St. Inc.
๐บ๐ธMiami, Florida, United States
Innovation Clinical Trials, Inc.
๐บ๐ธPalmetto Bay, Florida, United States
Atlanta VA Medical Center
๐บ๐ธDecatur, Georgia, United States
University of Kansas Medical Center
๐บ๐ธKansas City, Kansas, United States
Collective Medical Research.
๐บ๐ธPrairie Village, Kansas, United States
Maine Health
๐บ๐ธScarborough, Maine, United States
Maryland Treatment Centers
๐บ๐ธBaltimore, Maryland, United States
Baystate Health
๐บ๐ธSpringfield, Massachusetts, United States
Vida Clinical Studies
๐บ๐ธDearborn Heights, Michigan, United States
THRYV Clinical Studies
๐บ๐ธDearborn, Michigan, United States
North Point Medical Center
๐บ๐ธFair Haven, Michigan, United States
Psych Care Consultants
๐บ๐ธSaint Louis, Missouri, United States
DENT Neurologic Institute
๐บ๐ธAmherst, New York, United States
Icahn School of Medicine at Mount Sinai
๐บ๐ธNew York, New York, United States
Core Clinical Trials
๐บ๐ธNorth New Hyde Park, New York, United States
Stuart Wasser Practice
๐บ๐ธRockville Centre, New York, United States
Onsite Clinical Solutions LLC
๐บ๐ธCharlotte, North Carolina, United States
Pahl Pharmaceutical Professionals LLC
๐บ๐ธOklahoma City, Oklahoma, United States
VAST Clinical Research
๐บ๐ธSulphur, Oklahoma, United States
Healing Comfort Clinic, LLC
๐บ๐ธCorvallis, Oregon, United States
Thalia Medical Centre
๐บ๐ธNarberth, Pennsylvania, United States
Midlands Neurology
๐บ๐ธColumbia, South Carolina, United States
Prisma Health
๐บ๐ธGreenville, South Carolina, United States
Alpine Research Organization
๐บ๐ธClinton, Utah, United States
Drug and Alcohol Services South Australia (DASSA)
๐ฆ๐บStepney, South Australia, Australia
Eastern Health
๐ฆ๐บRichmond, Australia
Savera Medical Centre
๐จ๐ฆEdmonton, Ontario, Canada
Brightshores Health System
๐จ๐ฆOwen Sound, Ontario, Canada
Bluewater Rapid Assessment Addiction Medicine Clinic
๐จ๐ฆSarnia, Ontario, Canada
Comprehensive Treatment Clinic
๐จ๐ฆToronto, Ontario, Canada
Linkoping University Hospital, Psychiatry Center
๐ธ๐ชLinkรถping, Sweden