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. 2021 May:104:106359.
doi: 10.1016/j.cct.2021.106359. Epub 2021 Mar 16.

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  1 , Kathryn F Hawk  2 , Andrew A Herring  3 , Jeanmarie Perrone  4 , Ethan Cowan  5 , Ryan P McCormack  6 , James Dziura  2 , R Andrew Taylor  2 , Edouard Coupet  2 , E Jennifer Edelman  7 , Michael V Pantalon  2 , Patricia H Owens  2 , Shara H Martel  2 , Patrick G O'Connor  7 , Paul Van Veldhuisen  8 , Nicholas DeVogel  8 , Kristen Huntley  9 , Sean M Murphy  10 , Michelle R Lofwall  11 , Sharon L Walsh  11 , David A Fiellin  12
Affiliations

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 et al. Contemp Clin Trials. 2021 May.

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.

Keywords: Buprenorphine; Emergency medicine; Hybrid design; Implementation science; Opioid-related disorders.

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Conflict of interest statement

Declaration of interests

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1:
Figure 1:. Timeline
a Extra IF time for sites with no buprenorphine induction experience or referral sites that may need more assistance b Sites will come on board on a rolling basis when they achieve competency c Estimates due to multiple COVID delays
Figure 2.
Figure 2.
Location of Sites
Figure 3:
Figure 3:
SL BUP Algorithm
Figure 4:
Figure 4:
XR-BUP Injection algorithm
See this image and copyright information in PMC

References

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