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NCT06316830 · ClinicalTrials.gov registry record · Phase 2
Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose
A Phase 2 study of Opioid Use Disorder, sponsored by Rhode Island Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 250
- Enrollment target
- 1
- Study location
NCT06316830: Recruiting Phase 2 study of Opioid Use Disorder, sponsored by Rhode Island Hospital.
NCT06316830 is a Phase 2 study of Opioid Use Disorder that is actively recruiting participants, run by Rhode Island Hospital. The registered enrollment target is 250 participants, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06316830, a Phase 2 study of Opioid Use Disorder, is actively recruiting participants, sponsored by Rhode Island Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 250 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg). The main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved retention in buprenorphine treatment (primary outcome), improved treatment response based on use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (exploratory outcome).
Primary Outcome
The primary outcome is the percentage of participants retained in buprenorphine treatment. Participants will be classified as retained in buprenorphine treatment at six months post- randomization if (1) the study site data indicate that they remained engaged in treatment or (2) the PDMP suggest that they continued treatment elsewhere and have not had a gap of more than 27 days in medication on-hand based on fill dates and days' supply.
Conditions Studied
Interventions
- DRUG Buprenorphine
Study Locations (1)
Rhode Island
- Brown University - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2025-01-06 |
| Est. Completion | 2027-11-01 |
| Phase | Phase 2 |
What NCT06316830 shows while recruiting
NCT06316830 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which Buprenorphine is the first listed.
NCT06316830 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT06316830 about?
NCT06316830 is a clinical study titled "Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose". The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg). The main question it aims to answer is: will patients who are randomly assigned to the high ...
What is the current status of trial NCT06316830?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 2025-01-06. Estimated completion is 2027-11-01.
What conditions does trial NCT06316830 study?
This clinical trial studies the following conditions: Opioid Use Disorder.
What interventions are being tested in trial NCT06316830?
The interventions under investigation include: Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT06316830?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06316830 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Opioid Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06316830's enrollment target sits among peer trials
250 70th of 257 higher than 185 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder 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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