drugset / Trial / NCT06854029
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
Phase 4
Not yet recruiting
450 enrolled
Duke University
Friends Research Institute, Inc. · collabNational Institute on Drug Abuse (NIDA) · collabThe Miriam Hospital · collabUniversity of Arkansas · collab
Non-randomizedParallel-groupSingle-blindPrevention
Summary
The investigators plan to conduct an R61/33 hybrid type 2 implementation-effectiveness trial that includes 1) a one-year exploratory R61 phase that will enable the development of the intervention protocol needed for the R33 trial phase including concrete R61 phase milestones; 2) a four-year R33 phase that will include a concurrent implementation evaluation and a randomized control trial.
Timeline
- Start
- 2026-07-01
- Primary completion
- 2029-12-01
- Completion
- 2030-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | — | Other |
| Subject | Cabotegravir | Small molecule | — | Other |