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

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

doi:10.1016/j.cct.2021.106359

Cited by 15 publications

(15 citation statements)

References 27 publications

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“…This cohort study used data from the first, to our knowledge, prospective trial using uniform surveillance, operational definitions, and adjudicated outcomes to document buprenorphine-induced PW in persons using fentanyl. Despite high fentanyl prevalence, the incidence of PW in this multisite trial of ED-initiated buprenorphine was less than 1%, similar to reported rates among persons using heroin or prescription opioids . All 9 patients with PW used fentanyl, most without PW also used fentanyl, and no factors suggest a specific phenotype for PW.…”

Section: Discussionmentioning

confidence: 99%

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Incidence of Precipitated Withdrawal During a Multisite Emergency Department–Initiated Buprenorphine Clinical Trial in the Era of Fentanyl

et al. 2023

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Section: Discussionmentioning

confidence: 99%

“…This observational cohort study using data from an ongoing clinical trial included patients aged 18 years or older with moderate-to-severe opioid use disorder, opioid-positive and methadone-negative urine tests, and a Clinical Opiate Withdrawal Scale (COWS) score of 4 or higher. Pregnant or admitted patients were excluded.…”

Section: Methodsmentioning

confidence: 99%

Incidence of Precipitated Withdrawal During a Multisite Emergency Department–Initiated Buprenorphine Clinical Trial in the Era of Fentanyl

et al. 2023

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“…The ED INNOVATION randomized controlled trial seeks to test if these patient‐ and clinician‐level barriers to follow‐up care are affected by different formulation of buprenorphine such as a long acting 7‐day injectable BUP compared to the standard sublingual preparation. 28 …”

Section: Discussionmentioning

confidence: 99%

“… 28 The ED‐INNOVATION protocol has been published elsewhere. 28 Briefly, the study has 2 components: (1) an implementation phase using implementation facilitation to enhance adoption of ED‐initiated BUP and (2) a randomized controlled trial comparing the effectiveness of 2 BUP formulations, sublingual (SL‐BUP) and a 7‐day extended‐release injectable (CAM2038, XR‐BUP) among patients with OUD on the primary outcome of engagement in formal addiction treatment at 7 days. 28 , 29 As part of the implementation facilitation phase but before initiation of any associated support efforts, all sites were required to submit their clinical BUP initiation protocols for review by the lead research team before October 31, 2020.…”

Section: Methodsmentioning

confidence: 99%

Emergency department‐initiated buprenorphine protocols: A national evaluation

et al. 2021

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Objective Emergency department‐initiated buprenorphine (BUP) for opioid use disorder is an evidence‐based practice, but limited data exist on BUP initiation practices in real‐world settings. We sought to characterize protocols for BUP initiation among a geographically diverse sample of emergency departments (EDs). Methods In December 2020, we reviewed prestudy clinical BUP initiation protocols from all EDs participating in CTN0099 Emergency Department‐INitiated bupreNOrphine VAlidaTION (ED‐INNOVATION). We abstracted information on processes for identification of treatment‐eligible patients, BUP administration, and discharge care. Results All participating ED‐INNOVATION sites across 22 states submitted protocols; 31 protocols were analyzed. Identification of treatment‐eligible patients : Most EDs 22 (71%) relied on clinician judgment to determine appropriateness of BUP treatment with only 7 (23%) requiring decision support tools or diagnosis checklists. Before BUP initiation, 27 (87%) protocols required a documented Clinical Opiate Withdrawal Scale (COWS) score; 4 (13%) required a clinical diagnosis of withdrawal with optional COWS score. Twenty‐seven (87%) recommended a minimum COWS score of 8 for ED‐initiated BUP. BUP administration : Initial BUP dose ranged from 2–16 mg (mode = 4). For continued withdrawal symptoms, 27 (87%) protocols recommended an interval of 30–60 minutes between first and second BUP dose. Total BUP dose in the ED ranged from 8 to 32 mg. Discharge care : Twenty‐eight (90%) protocols recommended a BUP prescription (mode 16 mg daily) at discharge. Naloxone prescription and/or provision was suggested in 23 (74%) protocols. Conclusions In this geographically diverse sample of EDs, protocols for ED‐initiated BUP differed between sites. Future work should evaluate the association between this variation and patient outcomes.

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“…21,22 A new 7-day injectable formulation of buprenorphine may eliminate some of the patient-related barriers to continued treatment and follow-up after the ED visit. 23 Buprenorphine is available as a mono-product and in combination with naloxone in sublingual films and tablets. Naloxone was added to the formulation to deter diversion and misuse of the product.…”

Section: Buprenorphinementioning

confidence: 99%

Guidance for emergency medicine pharmacists to improve care for people with opioid use disorder

Kelsch

Bailey

Baum

et al. 2021

J Am Coll Clin Pharm

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The Emergency Medicine Pharmacist (EMP) is uniquely trained to play a vital role in the management of patients who use opioids and patients with opioid use disorder (OUD). The emergency department (ED) is at the forefront of the opioid epidemic, as it serves as a primary place of treatment for patients experiencing opioid overdose, opioid withdrawal, and other complications related to opioid use. Given the size of

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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

Cited by 15 publications

References 27 publications

Incidence of Precipitated Withdrawal During a Multisite Emergency Department–Initiated Buprenorphine Clinical Trial in the Era of Fentanyl

Incidence of Precipitated Withdrawal During a Multisite Emergency Department–Initiated Buprenorphine Clinical Trial in the Era of Fentanyl

Emergency department‐initiated buprenorphine protocols: A national evaluation

Guidance for emergency medicine pharmacists to improve care for people with opioid use disorder

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