Evaluating the SUBLOCADE Treatment Exit Strategy
Purpose
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.
Condition
- Opioid Use Disorder
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
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 Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
More Details
- NCT ID
- NCT05878210
- Status
- Active, not recruiting
- Sponsor
- Indivior Inc.
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.