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Completed

NCT Number: NCT05878210

Evaluating the SUBLOCADE Treatment Exit Strategy

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Savera Medical Centre, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  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:

    Time frame: 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

    Time frame: 6 months

    Yes/No

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

    Time frame: 6 months

    Yes/No

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

    Time frame: 6 months

    Yes/No

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

    Time frame: 6 months

    Yes/No

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

    Time frame: 6 months

    Yes/No

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Indivior Inc.

Industry

Registry information

Official study title

A Phase IV Study to Evaluate the SUBLOCADE Treatment Exit Strategy

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 26, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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