SUBLOCADE Rapid Initiation Extension Study

• Status: Completed
• Trial end date: 2020-05-15
• Target enrollment: 0
• Participant gender: All

Summary

A single center, open-label SUBLOCADE treatment extension study in which up to 25 participants diagnosed with moderate to severe opioid use disorder (OUD) could be enrolled.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indivior Inc.
• Treatments: Buprenorphine

Criteria

Inclusion Criteria:

• Signed the informed consent form (ICF) and have the ability to comply with the requirements and restrictions listed therein.

• Completed the EOT Visit for the INDV-6000-403 Study.

• Is an appropriate candidate in the opinion of the Investigator or medically qualified sub-Investigator.

Exclusion Criteria:

• Subject compliance issues during participation in the INDV-6000-403 study which, in the opinion of the Investigator, could potentially compromise subject safety.

• Subjects who are unable, in the opinion of the Investigator or Indivior, to comply fully with the study requirements including those who are currently incarcerated or pending incarceration legal action.