Evaluating the SUBLOCADE Treatment Exit Strategy

A Phase IV Study to Evaluate 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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6E6T9
      • Savera Medical Centre
• United States
  • Maine
    • Portland, Maine, United States, 04102
      • Comprehensive Addiction Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with a history of OUD, who have been on SUBLOCADE treatment for at least 12 injections, have disease symptoms controlled for at least 9 months in the opinion of the healthcare provider, and discontinue SUBLOCADE treatment.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful taper by the end of 6-month follow-up.	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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:	Average clinical experience score (range: 0 to 4 with higher score = worse outcome) on opioid withdrawal severity during the past month	6 months
Participants restarting MOUD (yes/no) during study follow-up	Yes/No	6 months
Participants who reported withdrawal symptoms (yes/no) during the past month	Yes/No	6 months
Participants who used ancillary medications to treat opioid withdrawal symptoms (yes/no) during the past month	Yes/No	6 months
Participants who used rescue MOUD (yes/no) to treat opioid withdrawal symptoms during the past month	Yes/No	6 months
Participants who had self-reported illicit/nonmedical opioid use (yes/no) during the past month	Yes/No	6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2023
• Primary Completion (Actual): May 9, 2025
• Study Completion (Actual): May 9, 2025

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Medicine for Opioid Use Disorder (MOUD)
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: INDV-6000-407

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No