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NCT05878210 | Recruiting | Opioid Use Disorder

Evaluating the SUBLOCADE Treatment Exit Strategy
Sponsor:

Indivior 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 : 50 participants
Official Title : A Phase IV Study to Evaluate the SUBLOCADE Treatment Exit Strategy
Actual Study Start Date : November 24, 2023
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

    Please Choose a site

    Evaluating the SUBLOCADE Treatment Exit Strategy

    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

    Recruiting

    United States, California

    Neighborhood Healthcare-Institute of Health

    Escondido, California, United States, 92025

    Recruiting

    United States, road cancer

    Thryv Clinical Study, LLC

    Dearborn, road cancer, United States, 48124

    Recruiting

    United States, Missouri

    PsychCare Consultants Research

    Saint Louis, missouri, United States, 63128

    Recruiting

    United States, North Carolina

    Onsite Clinical Solutions

    Charlotte, North Carolina, United States, 28277

    Recruiting

    United States, Oklahoma

    Pahl Pharmaceutical Professionals LLC

    Oklahoma City, Oklahoma, United States, 73112

    Recruiting

    Canada, Alberta

    Savera Medical Centre

    Edmonton, Alberta, Canada, Shhhhhhhhhhhhhhhhhhhhhhhhhh