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 ≥ 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 ≥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 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 (53)
Wayne State University Hospital
🇺🇸Detroit, Michigan, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
St Vincent's Hospital Melbourne
🇦🇺Fitzroy, Melbourne, Australia
Turning Point
🇦🇺Richmond, Australia
Recovery Alberta
🇨🇦Edmonton, Alberta, Canada
Fraser Health Authority
🇨🇦Surrey, British Columbia, Canada
Dr. J.S. Dhillon Medicine Prof. Corp
🇨🇦Burlington, Ontario, Canada
ATP Clinical Research
🇺🇸Costa Mesa, California, United States
Neighborhood Healthcare-Institute of Health
🇺🇸Escondido, California, United States
Elevate Health and Wellness
🇺🇸Westport, Connecticut, United States
United Research Institute
🇺🇸Hialeah, Florida, United States
Zenith Clinical Research LLC
🇺🇸Hollywood, Florida, United States
Jackson Health Community Center
🇺🇸Miami, Florida, United States
G+C Research Group
🇺🇸Miami, Florida, United States
Innovation Clinical 8 St. Inc.
🇺🇸Miami, Florida, United States
Innovation Clinical Trials, Inc.
🇺🇸Palmetto Bay, Florida, United States
Atlanta VA Medical Center
🇺🇸Decatur, Georgia, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Collective Medical Research.
🇺🇸Prairie Village, Kansas, United States
Maine Health
🇺🇸Scarborough, Maine, United States
Maryland Treatment Centers
🇺🇸Baltimore, Maryland, United States
Baystate Health
🇺🇸Springfield, Massachusetts, United States
Vida Clinical Studies
🇺🇸Dearborn Heights, Michigan, United States
THRYV Clinical Studies
🇺🇸Dearborn, Michigan, United States
North Point Medical Center
🇺🇸Fair Haven, Michigan, United States
SHMG Center for Integrative Medicine
🇺🇸Grand Rapids, Michigan, United States
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
Psych Care Consultants
🇺🇸Saint Louis, Missouri, United States
DENT Neurologic Institute
🇺🇸Amherst, New York, United States
United Health Services
🇺🇸Binghamton, New York, United States
Core Clinical Trials
🇺🇸N. New Hyde Park, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Stuart Wasser Practice
🇺🇸Rockville Centre, New York, United States
Onsite Clinical Solutions LLC
🇺🇸Charlotte, North Carolina, United States
Pahl Pharmaceutical Professionals LLC
🇺🇸Oklahoma City, Oklahoma, United States
VAST Clinical Research
🇺🇸Sulphur, Oklahoma, United States
Healing Comfort Clinic, LLC
🇺🇸Corvallis, Oregon, United States
Thalia Medical Centre
🇺🇸Narberth, Pennsylvania, United States
Charleston Pain and Rehabilitation Center
🇺🇸Charleston, South Carolina, United States
Midlands Neurology
🇺🇸Columbia, South Carolina, United States
Prisma Health
🇺🇸Greenville, South Carolina, United States
Biopharma Informatic, Inc. Research Center
🇺🇸Houston, Texas, United States
Alpine Research Organization
🇺🇸Clinton, Utah, United States
John Hunter Hospital
🇦🇺Newcastle, New South Wales, Australia
Drug and Alcohol Services South Australia (DASSA)
🇦🇺Stepney, South Australia, Australia
Smart Clinic
🇨🇦Calgary, Alberta, Canada
Savera Medical Centre
🇨🇦Edmonton, Ontario, Canada
The Stipley Clinic
🇨🇦Hamilton, Ontario, Canada
Brightshores Health System
🇨🇦Owen Sound, Ontario, Canada
Bluewater Rapid Assessment Addiction Medicine Clinic
🇨🇦Sarnia, Ontario, Canada
Comprehensive Treatment Clinic
🇨🇦Toronto, Ontario, Canada
Linkoping University Hospital, Psychiatry Center
🇸🇪Linköping, Sweden
Beroendecentrum
🇸🇪Stockholm, Sweden