Evaluating the SUBLOCADE Treatment Exit Strategy

Opioid Use Disorder Clinical Trial

Official title:

A Phase IV Study to Evaluate the SUBLOCADE Treatment Exit Strategy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05878210
• Other study ID #: INDV-6000-407
• Status: Recruiting
• Start date: November 24, 2023
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Indivior Inc.
• Contact: Global Director Clinical Development
• Phone: (804) 594-4488
• Email: trialdisclosure[@]indivior.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Locations

Country	Name	City	State
Canada	Savera Medical Centre	Edmonton	Alberta
United States	Onsite Clinical Solutions	Charlotte	North Carolina
United States	Thryv Clinical Study, LLC	Dearborn	Michigan
United States	Neighborhood Healthcare-Institute of Health	Escondido	California
United States	Pahl Pharmaceutical Professionals LLC	Oklahoma City	Oklahoma
United States	PsychCare Consultants Research	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Indivior Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Participants restarting MOUD (yes/no) during study follow-up	Yes/No	6 months
Secondary	Participants who reported withdrawal symptoms (yes/no) during the past month	Yes/No	6 months
Secondary	Participants who used ancillary medications to treat opioid withdrawal symptoms (yes/no) during the past month	Yes/No	6 months
Secondary	Participants who used rescue MOUD (yes/no) to treat opioid withdrawal symptoms during the past month	Yes/No	6 months
Secondary	Participants who had self-reported illicit/nonmedical opioid use (yes/no) during the past month	Yes/No	6 months