Evaluating the SUBLOCADE Treatment Exit Strategy

Indivior

Status: Completed

Conditions: Opioid Use Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT05878210

INDV-6000-407

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.