CompletedPhase 4

SUBLOCADE Rapid Initiation Extension Study

United States17 participantsStarted 2019-10-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Treatment Emergent Adverse Event (TEAE) Occurrence

Timeframe: From time of informed consent at Day 1 until EOT, assessed up until Day 141

Trial details

NCT IDNCT04060654

SponsorIndivior Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-05-15

Results submitted2021-01-05

View on ClinicalTrials.gov More Opioid Use Disorder, Severe trials