Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose
Recruiting
Phase 2
Phase 3
Interventional Study
Opioid Use Disorder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 250 (estimated)
- Sponsor
- Rhode Island Hospital · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* English-speaking
* Age 18 years-old or older
* Identified by the treating physician as having moderate to severe opioid use disorder (OUD)
* Initiating or continuing buprenorphine for treatment of opioid use disorder
* History of fentanyl use (confirmed by fentanyl positive ur…
Contacts