drugset / Trial / NCT03747341
Buprenorphine-Fentanyl Interaction Study
RandomizedCrossoverSingle-blindPrevention
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
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 |