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Evaluating the SUBLOCADE Treatment Exit Strategy

Sponsor
Indivior Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05878210
Collaborator
(none)
50
Enrollment
15
Anticipated Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Phase IV Study to Evaluate the SUBLOCADE Treatment Exit Strategy
    Anticipated Study Start Date :
    Jun 1, 2023
    Anticipated Primary Completion Date :
    Sep 1, 2024
    Anticipated Study Completion Date :
    Sep 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Rate of successful taper by the end of 6-month follow-up. [6 months]

      Successful taper is defined as no consistent self-reported illicit/nonmedical opioid use and not restarting long-term MOUD treatment due to opioid withdrawal or illicit/nonmedical opioid use during follow up. Consistent self-reported illicit/nonmedical opioid use is defined as self-reported 4 consecutive use weeks (ie, weeks with at least 1 day of illicit/nonmedical opioid use per week) or 7 consecutive days of illicit/nonmedical opioid use.

    Secondary Outcome Measures

    1. 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: [6 months]

      Average clinical experience score (range: 0 to 4 with higher score = worse outcome) on opioid withdrawal severity during the past month

    2. Participants restarting MOUD (yes/no) during study follow-up [6 months]

      Yes/No

    3. Participants who reported withdrawal symptoms (yes/no) during the past month [6 months]

      Yes/No

    4. Participants who used ancillary medications to treat opioid withdrawal symptoms (yes/no) during the past month [6 months]

      Yes/No

    5. Participants who used rescue MOUD (yes/no) to treat opioid withdrawal symptoms during the past month [6 months]

      Yes/No

    6. Participants who had self-reported illicit/nonmedical opioid use (yes/no) during the past month [6 months]

      Yes/No

    Eligibility Criteria

    Criteria

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

    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Indivior Inc.

    Investigators

    • Study Director: (804) 594-4488, Indivior Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Indivior Inc.
    ClinicalTrials.gov Identifier:
    NCT05878210
    Other Study ID Numbers:
    • INDV-6000-407
    First Posted:
    May 26, 2023
    Last Update Posted:
    May 26, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Indivior Inc.
    Medicine for Opioid Use Disorder (MOUD)
    Additional relevant MeSH terms:
    Opioid-Related Disorders

    Study Results

    No Results Posted as of May 26, 2023