Standard Versus High Dose ED-Initiated Buprenorphine Induction

Phase 3 Recruiting 360 enrolled Yale University Alameda Health System · collab National Drug Abuse Treatment Clinical Trials Network · collab National Institute on Drug Abuse (NIDA) · collab The Emmes Company, LLC · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This study is a multisite double-blind, double-dummy, randomized clinical trial enrolling ED patients with untreated moderate to severe opioid use disorder (OUD) to compare Standard Dose Induction (SDI) and High Dose Induction (HDI) on rates of participation in OUD treatment within 10 days post randomization, and opioid withdrawal symptoms, opioid craving, and use of illicit and non-prescribed drugs.

Timeline

Start: 2024-12-06
Primary completion: 2027-09
Completion: 2028-12

Publications

Hawk K, Herring A, Chawarski M, Anderson ES, Baumann M, Dorey A, Holtyn AF, Jones C, Martel S, Owens P, Kmiecik K, Strout TD, Taillac P, Lofwall M, Walsh SL, D'Onofrio G. Emergency Department-initiated standard versus high-dose buprenorphine induction (ENVISION): a randomised clinical trial protocol. BMJ Open. 2026 Jun 3;16(6):e113762. doi: 10.1136/bmjopen-2025-113762.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Buprenorphine	Other / unclassified	5.7 mg	—
Subject	Buprenorphine	Other / unclassified	17.1 mg	—

Standard Versus High Dose ED-Initiated Buprenorphine Induction

Summary

Timeline

Publications

Drugs

Indications