Phase 4
N=17
SUBLOCADE Rapid Initiation Extension Study
Opioid Use Disorder, Severe · Opioid Use Disorder, Moderate
Bottom Line
View on ClinicalTrials.gov: NCT04060654 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Treatment Emergent Adverse Event (TEAE) Occurrence — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sublocade (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indivior Inc.
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Emergent Adverse Event (TEAE) Occurrence |
— | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04060654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.