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NCT05878210 | ACTIVE NOT RECRUITING | Opioid Use Disorder

Evaluating the SUBLOCADE Treatment Exit Strategy
Sponsor:

Indivate Inc.

Brief Summary:

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.

Condition or disease

Opioid Use Disorder

Detailed Description:

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 25 participants
Official Title : A Phase IV Study to Evaluate the SUBLOCADE Treatment Exit Strategy
Actual Study Start Date : 2023-11-24
Estimated Primary Completion Date : 2025-05
Estimated Study Completion Date : 2025-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
      • * Has been treated with at least 12 injections of SUBLOCADE.
      • * In the opinion of the investigator, has had their OUD symptoms (ie, overdose, illicit/nonmedical use, withdrawal) controlled for at least 9 months.
      • * In the opinion of the investigator, has had any other substance use disorder (excluding alcohol, nicotine, or cannabis) symptoms controlled for at least 9 months.
      • * 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.
    • Evaluating the SUBLOCADE Treatment Exit Strategy

    Location Details

    NCT05878210

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    United States, Maine

    Comprehensive Addiction Medicine

    Portland, Maine, United States, 04102

    Not yet recruiting

    Canada, Alberta

    Savera Medical Centre

    Edmonton, Alberta, Canada, Politness