Evaluating the SUBLOCADE Treatment Exit Strategy

NCT05878210 | Completed

• 1 other identifier: INDV-6000-407
• Study Type: observational
• Target: 12
• Locations: 2 countries
• Sites: 2

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.

Conditions

Opioid Use Disorder

Keywords

Medicine for Opioid Use Disorder (MOUD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• Participants restarting MOUD (yes/no) during study follow-up

  6 months

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

  6 months

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

  6 months

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

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (2)

Comprehensive Addiction Medicine

Portland, Maine, 04102, United States

Location

Savera Medical Centre

Edmonton, Alberta, T6E6T9, Canada

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• (804) 594-4488

  Indivior Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 26, 2023
• Study Start: November 24, 2023
• Primary Completion: May 9, 2025
• Study Completion: May 9, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (1)