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The purpose of this study is to observe and assess the successful taper and opioid withdrawal experience after participants stop receiving SUBLOCADE because their healthcare provider determines their disease symptoms have been controlled for at least 9 months and they, together with their healthcare provider, plan to discontinue MOUD.
This is a Phase IV, observational, multicentre, open-label, study in participants with a history of OUD, who have been on SUBLOCADE treatment for at least 12 injections, have had disease symptoms controlled for at least 9 months in the opinion of the healthcare provider, and both healthcare provider and participant plan to discontinue MOUD treatment.
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of successful taper by the end of 6-month follow-up. |
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Key secondary - At each given month, for participants not restarting MOUD and not consistently using illicit/nonmedical opioid up to the start of that month: | Average clinical experience score (range: 0 to 4 with higher score = worse outcome) on opioid withdrawal severity during the past month | 6 months |
| Participants restarting MOUD (yes/no) during study follow-up |
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Inclusion Criteria
Participants must meet all of the following criteria:
The participant, together with their healthcare provider (the investigator), have previously determined that it is appropriate to stop MOUD treatment, and the participant meets the following criteria:
Is willing to complete the Baseline Visit 4 to 8 weeks after the last dose of SUBLOCADE.
Has signed the ICF and is 18 years of age or older.
Is not currently using opioids to treat a diagnosis other than OUD.
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Participants with a history of OUD, who have been on SUBLOCADE treatment for at least 12 injections, have disease symptoms controlled for at least 9 months in the opinion of the healthcare provider, and discontinue SUBLOCADE treatment.
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| Name | Affiliation | Role |
|---|---|---|
| (804) 594-4488 | Indivior Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Addiction Medicine | Portland | Maine | 04102 | United States | ||
| Savera Medical Centre |
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| 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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Yes/No |
| 6 months |
| Participants who reported withdrawal symptoms (yes/no) during the past month | Yes/No | 6 months |
| Participants who used ancillary medications to treat opioid withdrawal symptoms (yes/no) during the past month | Yes/No | 6 months |
| Participants who used rescue MOUD (yes/no) to treat opioid withdrawal symptoms during the past month | Yes/No | 6 months |
| Participants who had self-reported illicit/nonmedical opioid use (yes/no) during the past month | Yes/No | 6 months |
| Edmonton |
| Alberta |
| T6E6T9 |
| Canada |