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NCT06854029 · ClinicalTrials.gov registry record · Phase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
A Phase 4 study, sponsored by Duke University.
- Not yet
- Registry status
- Phase 4
- Development phase
- 450
- Enrollment target
NCT06854029: Clinical Trial Phase 4 study, sponsored by Duke University.
NCT06854029 is a Phase 4 study that has not yet begun recruiting, run by Duke University. The registered enrollment target is 450 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06854029, a Phase 4 study, has not yet begun recruiting, sponsored by Duke University.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 450 participants
- Enrollment target
Study 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.
Primary Outcome
Dropout is defined as missing treatment for 7 consecutive days.
Interventions
- DRUG Cabotegravir Injection
- DRUG Cabotegravir Pill
- DRUG Buprenorphine injection
- DRUG Buprenorphine Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2030-06-01 |
| Phase | Phase 4 |
What is known before NCT06854029 opens enrollment
NCT06854029 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 4 interventions - of which Cabotegravir Injection is the first listed.
NCT06854029 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06854029 about?
NCT06854029 is a clinical study titled "NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings". 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 phas...
What is the current status of trial NCT06854029?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 450 participants. The study started on 2026-07-01. Estimated completion is 2030-06-01.
What interventions are being tested in trial NCT06854029?
The interventions under investigation include: Cabotegravir Injection (DRUG), Cabotegravir Pill (DRUG), Buprenorphine injection (DRUG), Buprenorphine Pill (DRUG).
Who is sponsoring clinical trial NCT06854029?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06854029's enrollment target sits among peer trials
450 187th of 2000 higher than 1,813 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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