Buprenorphine-Fentanyl Interaction Study

Summary

An increase in overdose deaths has been attributed to widespread access to fentanyl and carfentanyl. The study is designed to determine if buprenorphine can change the respiratory depression response to intravenous (IV) fentanyl.

Timeline

Start

2018-03-22

Primary completion

2019-01-04

Completion

2019-01-04

Outcome

Met primary endpoint

paper 26% (13-40%) and 47% (37-59%) compared to 51% (38-64%) and 79% (69-89%) during placebo infusion (p = 0.001 and < .001, respectively). PMID 35085249 ↗

paper fentanyl reduced VE up to 49% (21-76%) during buprenorphine infusion (all concentration groups combined) versus up to 100% (68-132%) during placebo infusion (p = 0.006). PMID 35085249 ↗

Publications

• Background Olofsen E, Algera MH, Moss L, Dobbins RL, Groeneveld GJ, van Velzen M, Niesters M, Dahan A, Laffont CM. Modeling buprenorphine reduction of fentanyl-induced respiratory depression. JCI Insight. 2022 May 9;7(9):e156973. doi: 10.1172/jci.insight.156973.
• Results Moss LM, Algera MH, Dobbins R, Gray F, Strafford S, Heath A, van Velzen M, Heuberger JAAC, Niesters M, Olofsen E, Laffont CM, Dahan A, Groeneveld GJ. Effect of sustained high buprenorphine plasma concentrations on fentanyl-induced respiratory depression: A placebo-controlled crossover study in healthy volunteers and opioid-tolerant patients. PLoS One. 2022 Jan 27;17(1):e0256752. doi: 10.1371/journal.pone.0256752. eCollection 2022.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Buprenorphine	Other / unclassified	0.000285714 mg/kg	Intravenous
Subject	Buprenorphine	Other / unclassified	0.000714286 mg/kg	Intravenous
Subject	Buprenorphine	Other / unclassified	0.00142857 mg/kg	Intravenous
Subject	Buprenorphine	Other / unclassified	0.00285714 mg/kg	Intravenous
Subject	Buprenorphine	Other / unclassified	0.00714286 mg/kg	Intravenous
Subject	Fentanyl	Other / unclassified	0.00107143 mg/kg	Intravenous
Subject	Fentanyl	Other / unclassified	0.00214286 mg/kg	Intravenous
Subject	Fentanyl	Other / unclassified	0.00357143 mg/kg	Intravenous
Subject	Fentanyl	Other / unclassified	0.005 mg/kg	Intravenous
Subject	Fentanyl	Other / unclassified	0.00714286 mg/kg	Intravenous
Subject	Fentanyl	Other / unclassified	0.01 mg/kg	Intravenous
Background	Ondansetron	Other / unclassified	4 mg	Other
Background	Oxycodone	Other / unclassified	—	Oral

Indications