Phase 4
Completed N=17
SUBLOCADE Rapid Initiation Extension Study
Opioid Use Disorder, Severe · Opioid Use Disorder, Moderate
Source: ClinicalTrials.gov NCT04060654 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Treatment Emergent Adverse Event (TEAE) Occurrence — 0 Participants
◆ Published Evidence
Emerging
11citations · ~6 / year
Open-label investigation of rapid initiation of extended-release buprenorphine in patients using fentanyl and fentanyl analogs.
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.
Linked Publications
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Open-label investigation of rapid initiation of extended-release buprenorphine in patients using fentanyl and fentanyl analogs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Emergent Adverse Event (TEAE) Occurrence |
— | — |
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) and the linked publication. 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. Informational only — not medical advice.