Status:
COMPLETED
SUBLOCADE Rapid Initiation Extension Study
Lead Sponsor:
Indivior Inc.
Conditions:
Opioid Use Disorder, Severe
Opioid Use Disorder, Moderate
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Detailed Description
This study is being conducted to assess the longer-term safety of an abbreviated initiation protocol of SUBLOCADE in subjects who have completed the INDV-6000-403 study. It is also to provide treatmen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2020
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04060654
Start Date
October 21 2019
End Date
May 15 2020
Last Update
March 25 2025
Active Locations (1)
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1
Hassman Research Institute
Berlin, New Jersey, United States, 08009