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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | DSM-5-Related | up to a maximum of 4 years |
| Among those starting SUBLOCADE within 3 months of study Baseline, time to achieve early remission for the first time while on initial SUBLOCADE treatment |
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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
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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Participants may enroll if they have initiated treatment with SUBLOCADE within 3 months prior to signing the informed consent form (ICF), or have completed an Indivior SUBLOCADE study (eg, INDV-6000-401, INDV-6000-405) and received their last dose of SUBLOCADE on the study within 3 months prior to signing the ICF, and plan to receive additional SUBLOCADE injections.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATP Clinical Research | Costa Mesa | California | 92626 | United States | ||
| Neighborhood Healthcare-Institute of Health |
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DSM-5-Related |
| up to a maximum of 4 years |
| Participants achieving DSM-5 sustained remission (yes/no) by 1, 1.5, 2, 2.5, and 3 years while on initial SUBLOCADE treatment | DSM-5-Related | up to a maximum of 4 years |
| Time to achieve sustained remission for the first time while on initial SUBLOCADE treatment | DSM-5-Related | up to a maximum of 4 years |
| 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 | MOUD Use and Retention | up to a maximum of 4 years |
| Participants switching from initial SUBLOCADE treatment to another MOUD (yes/no), and the corresponding reasons, eg, safety concerns, treatment failure, seeking alternative MOUD treatment | MOUD Use and Retention | up to a maximum of 4 years |
| The overall treatment duration for participants who stop initial SUBLOCADE treatment as the result of resolution of OUD symptoms | MOUD Use and Retention | up to a maximum of 4 years |
| 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 | Illicit Opioid Use (Self-Reports) | up to a maximum of 4 years |
| 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 | Opioid Overdose Requiring Intervention | up to a maximum of 4 years |
| Escondido |
| California |
| 92025 |
| United States |
| Elevate Health and Wellness | Westport | Connecticut | 06880 | United States |
| United Research Institute | Hialeah | Florida | 33012 | United States |
| Zenith Clinical Research LLC | Hollywood | Florida | 33021 | United States |
| Jackson Health Community Center | Miami | Florida | 33126 | United States |
| G+C Research Group | Miami | Florida | 33134 | United States |
| Atlanta VA Medical Center | Decatur | Georgia | 30033-4004 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Collective Medical Research. | Prairie Village | Kansas | 66210 | United States |
| Maine Health | Scarborough | Maine | 04074-7163 | United States |
| Maryland Treatment Centers | Baltimore | Maryland | 21229 | United States |
| Baystate Health | Springfield | Massachusetts | 01199 | United States |
| THRYV Clinical Studies | Dearborn | Michigan | 48124 | United States |
| Vida Clinical Studies | Dearborn Heights | Michigan | 48127 | United States |
| Wayne State University Hospital | Detroit | Michigan | 48201 | United States |
| North Point Medical Center | Fair Haven | Michigan | 48023 | United States |
| SHMG Center for Integrative Medicine | Grand Rapids | Michigan | 49503-4224 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| Psych Care Consultants | St Louis | Missouri | 63141-8704 | United States |
| DENT Neurologic Institute | Amherst | New York | 14226 | United States |
| United Health Services | Binghamton | New York | 13903 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Core Clinical Trials | North New Hyde Park | New York | 11042 | United States |
| Stuart Wasser Practice | Rockville Centre | New York | 11570 | United States |
| Onsite Clinical Solutions LLC | Charlotte | North Carolina | 28277 | United States |
| Pahl Pharmaceutical Professionals LLC | Oklahoma City | Oklahoma | 73112 | United States |
| Healing Comfort Clinic, LLC | Corvallis | Oregon | 97330 | United States |
| Thalia Medical Centre | Narberth | Pennsylvania | 19072 | United States |
| Charleston Pain and Rehabilitation Center | Charleston | South Carolina | 29407 | United States |
| Midlands Neurology | Columbia | South Carolina | 29205 | United States |
| Prisma Health | Greenville | South Carolina | 29605 | United States |
| Biopharma Informatic, Inc. Research Center | Houston | Texas | 77043 | United States |
| Alpine Research Organization | Clinton | Utah | 84015 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | United States |
| St Vincent's Hospital Melbourne | Fitzroy | Melbourne | 3065 | Australia |
| John Hunter Hospital | Newcastle | New South Wales | 2300 | Australia |
| Drug and Alcohol Services South Australia (DASSA) | Stepney | South Australia | 5069 | Australia |
| Turning Point | Richmond | VIC 3121 | Australia |
| Smart Clinic | Calgary | Alberta | T2E2R2 | Canada |
| Recovery Alberta | Edmonton | Alberta | T5J 3E4 | Canada |
| Fraser Health Authority | Surrey | British Columbia | V3T 0H1 | Canada |
| Dr. J.S. Dhillon Medicine Prof. Corp | Burlington | Ontario | L7M 4X9 | Canada |
| The Stipley Clinic | Hamilton | Ontario | L8N 1H3 | Canada |
| Brightshores Health System | Owen Sound | Ontario | N4K 6M9 | Canada |
| Bluewater Rapid Assessment Addiction Medicine Clinic | Sarnia | Ontario | N7T 5W9 | Canada |
| Comprehensive Treatment Clinic | Toronto | Ontario | M4J 1M3 | Canada |
| Linkoping University Hospital, Psychiatry Center | Linköping | 58185 | Sweden |
| Beroendecentrum | Stockholm | SE-11365 | Sweden |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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