Evaluating the SUBLOCADE Treatment Exit Strategy

Last updated: April 3, 2025
Sponsor: Indivior Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Opioid Use Disorder

Treatment

N/A

Clinical Study ID

NCT05878210
INDV-6000-407
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 25
Study Start date:
November 24, 2023
Estimated Completion Date:
May 31, 2025

Study 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.

Connect with a study center

  • Savera Medical Centre

    Edmonton, Alberta T6E6T9
    Canada

    Site Not Available

  • Neighborhood Healthcare-Institute of Health

    Escondido, California 92025
    United States

    Site Not Available

  • Comprehensive Addiction Medicine

    Portland, Maine 04102
    United States

    Site Not Available

  • Thryv Clinical Study, LLC

    Dearborn, Michigan 48124
    United States

    Site Not Available

  • PsychCare Consultants Research

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • United Health Services Hospitals

    Binghamton, New York 13903
    United States

    Site Not Available

  • Onsite Clinical Solutions

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Pahl Pharmaceutical Professionals LLC

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

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