Evaluating the SUBLOCADE Treatment Exit Strategy

Active, not recruiting

• Conditions: Opioid Use Disorder

• Registration Number: NCT05878210
• Lead 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.

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 Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-17
• Study First Posted: 2023-05-26
• Study Start: 2023-11-24
• Status Verified: 2025-03
• Primary Completion: 2025-05
• Study Completion: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Participants restarting MOUD (yes/no) during study follow-up	6 months	Yes/No
Participants who reported withdrawal symptoms (yes/no) during the past month	6 months	Yes/No
Participants who used ancillary medications to treat opioid withdrawal symptoms (yes/no) during the past month	6 months	Yes/No
Participants who used rescue MOUD (yes/no) to treat opioid withdrawal symptoms during the past month	6 months	Yes/No
Participants who had self-reported illicit/nonmedical opioid use (yes/no) during the past month	6 months	Yes/No
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

Trial Locations

Locations (2)

Comprehensive Addiction Medicine; 🇺🇸 Portland, Maine, United States

Savera Medical Centre; 🇨🇦 Edmonton, Alberta, Canada