The design and conduct of a randomized clinical trial comparing emergency department initiation of sublingual versus a 7-day extended-release injection formulation of buprenorphine for opioid use disorder: Project ED Innovation

Gail D'Onofrio, Kathryn F. Hawk, Andrew A. Herring, Jeanmarie Perrone, Ethan Cowan, Ryan P. McCormack, James Dziura, R. Andrew Taylor, Edouard Coupet, E. Jennifer Edelman, Michael V. Pantalon, Patricia H. Owens, Shara H. Martel, Patrick G. O'Connor, Paul Van Veldhuisen, Nicholas DeVogel, Kristen Huntley, Sean M. Murphy, Michelle R. Lofwall, Sharon L. WalshDavid A. Fiellin

Research output: Contribution to journalArticlepeer-review

18 Scopus citations

Abstract

ED-INNOVATION (Emergency Department-INitiated bupreNOrphine VAlidaTION) is a Hybrid Type-1 Implementation-Effectiveness multisite emergency department (ED) study funded through The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM efforts to increase access to medications for opioid use disorder (OUD). We use components of Implementation Facilitation to enhance adoption of ED-initiated buprenorphine (BUP) at approximately 30 sites. Subsequently we compare the effectiveness of two BUP formulations, sublingual (SL-BUP) and 7-day extended-release injectable (CAM2038, XR-BUP) in a randomized clinical trial (RCT) of approximately 2000 patients with OUD on the primary outcome of engagement in formal addiction treatment at 7 days. Secondary outcomes assessed at 7 and 30 days include self-reported opioid use, craving and satisfaction, health service utilization, overdose events, and engagement in formal addiction treatment (30 days) and receipt of medications for OUD (at 7 and 30 days). A sample size of 1000 per group provides 90% power at the 2-sided significance level to detect a difference in the primary outcome of 8% and accommodates a 15% dropout rate. We will compare the cost effectiveness of the two treatments on the primary outcome using the incremental cost-effectiveness ratio. We will also conduct an ancillary study in approximately 75 patients experiencing minimal to no opioid withdrawal who will undergo XR-BUP initiation. If the ancillary study demonstrates safety, we will expand the eligibility criteria for the RCT to include individuals with minimal to no opioid withdrawal. The results of these studies will inform implementation of ED-initiated BUP in diverse EDs which has the potential to improve treatment access.

Original languageEnglish
Article number106359
JournalContemporary Clinical Trials
Volume104
DOIs
StatePublished - May 2021

Bibliographical note

Publisher Copyright:
© 2021

Funding

This research was supported by the National Institutes of Health through the NIH HEAL Initiative sm under award number 3UG1DA015831-18S7.

FundersFunder number
National Institutes of Health (NIH)
Author National Institute on Drug Abuse DA031791 Mark J Ferris National Institute on Drug Abuse DA006634 Mark J Ferris National Institute on Alcohol Abuse and Alcoholism AA026117 Mark J Ferris National Institute on Alcohol Abuse and Alcoholism AA028162 Elizabeth G Pitts National Institute of General Medical Sciences GM102773 Elizabeth G Pitts Peter McManus Charitable Trust Mark J Ferris National Institute on Drug AbuseUG1DA015831
Author National Institute on Drug Abuse DA031791 Mark J Ferris National Institute on Drug Abuse DA006634 Mark J Ferris National Institute on Alcohol Abuse and Alcoholism AA026117 Mark J Ferris National Institute on Alcohol Abuse and Alcoholism AA028162 Elizabeth G Pitts National Institute of General Medical Sciences GM102773 Elizabeth G Pitts Peter McManus Charitable Trust Mark J Ferris National Institute on Drug Abuse

    Keywords

    • Buprenorphine
    • Emergency medicine
    • Hybrid design
    • Implementation science
    • Opioid-related disorders

    ASJC Scopus subject areas

    • Pharmacology (medical)

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