Clinical trial · Interventional
SUBLOCADE Rapid Initiation Extension Study
An Open-label, Treatment Extension Study for the Rapid Initiation of Extended-Release Buprenorphine Subcutaneous Injection (SUBLOCADE™)
NCT04060654CI-TRIAL-00087654completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Opioid Use Disorder, Moderate | — | UNRESOLVED | — |
| Opioid Use Disorder, Severe | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sublocade | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SUBLOCADE
- description
- All subjects will receive SUBLOCADE 300mg on Day 1, followed by injections every 4 weeks at a dose determined by the Investigator (either 100 mg or 300 mg) for up to 5 total injections
- interventionNames
- Drug: Sublocade
Primary outcomes (1)
- measure
- Treatment Emergent Adverse Event (TEAE) Occurrence
- timeFrame
- From time of informed consent at Day 1 until EOT, assessed up until Day 141
- description
- Study will report the number of participants with the occurrence of any TEAE during the treatment period.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTMariani JJ, Dobbins RL, Heath A, Gray F, Hassman H. Open-label investigation of rapid initiation of extended-release buprenorphine in patients using fentanyl and fentanyl analogs. Am J Addict. 2024 Jan;33(1):8-14. doi: 10.1111/ajad.13484. Epub 2023 Nov 8. PMID 37936553