High-dose buprenorphine induction protocol for Opioid Use Disorder in emergency department settings
Photo by Teslariu Mihai / Unsplash
Key Takeaway
Note that this is a protocol only; no clinical results or data regarding buprenorphine efficacy are available.
This randomized clinical trial protocol outlines a study design for patients with moderate-to-severe Opioid Use Disorder (OUD) presenting in an emergency department setting. The planned sample size is 360 participants. The primary objective is to evaluate the rate of OUD treatment participation within 10 days post-randomization.
The intervention group will receive high-dose buprenorphine induction (24 mg buprenorphine equivalent). This will be compared against a standard-dose buprenorphine induction (8 mg buprenorphine equivalent). Secondary outcomes include opioid craving, opioid withdrawal symptoms, illicit drug use, and rates of OUD treatment participation within 30 days post-randomization.
Safety data, including adverse events, serious adverse events, and tolerability, are not reported as the study has not been conducted. The primary limitation is that this is a protocol; therefore, no clinical outcomes or results are available for interpretation at this time.
The proposed study aims to inform strategies for buprenorphine treatment initiation in emergency department settings. Clinical application of these findings remains pending the completion of the trial.
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View Original Abstract ↓
INTRODUCTION: The initiation of buprenorphine for patients with opioid use disorder (OUD) in the emergency department (ED) has been associated with improved outcomes including reduced ED visits and increased treatment engagement. Though both standard-dose (8 mg buprenorphine equivalent) and high-dose (24 mg buprenorphine equivalent) strategies to initiate buprenorphine have been used in the ED, no prospective trials comparing outcomes among patients receiving these treatments have been reported.
METHODS AND ANALYSIS: This multisite randomised clinical trial is a multisite double-blind, double-dummy, randomised clinical trial enrolling 360 emergency department patients with moderate-to-severe OUD. Enrolled patients will be randomised to one of two study arms: standard-dose induction or high-dose induction, both provided in the ED. This study will engage, train and provide resources to five EDs throughout the US to recruit patients with untreated OUD into a randomised clinical trial. The primary aim is to evaluate the effects of the standard-dose induction and high-dose induction on rates of OUD treatment participation within 10 days post-randomisation. The secondary aims are to evaluate differences between standard-dose induction and high-dose induction on the outcomes of opioid craving, opioid withdrawal symptoms and illicit drug use assessed during 10 days post randomisation and evaluate the effects between treatment arms on rates of OUD treatment participation within 30 days post randomisation.
ETHICS AND DISSEMINATION: This study is funded by the National Institute on Drug Abuse and has been approved by the WCG Instutitional Review Board. It has been registered at clinicaltrials.gov. This study will inform the strategy for treatment initiation with buprenorphine among diverse ED settings and will provide ongoing evidence to support the safety and efficacy of initiating treatment for OUD in the ED.
TRIAL REGISTRATION NUMBER: NCT06494904.
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