High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)

Recruiting 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.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
140 (estimated)
Sponsor
Rutgers, The State University of New Jersey · Other
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About This Trial
This project, involving two distinct clinical trials, tests whether induction to a higher than currently recommended buprenorphine (BUP) induction dose is safe and can improve the proportion of patients who engage in comprehensive addiction services within 7-day of induction. Trial 1 is a head-to-head comparison of the safety, tolerability and feasibility of high dose BUP induction (32 mg). The s…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study * Treated in the ED during screening hours * Meet DSM-5 diagnostic criteria for moderate to severe OUD * Clinical Opioid …
Contacts

Ethan Cowan, MD, MS

(917) 447-4964

ethan.cowan@rutgers.edu

CONTACT

Clare O'Brien-Lambert

co442@njms.rutgers.edu

CONTACT