Fentanyl hameln 50 microgram/ml

DRUG5 trials

Sponsors

Amsterdam UMC, Leiden University Medical Center, Academisch Ziekenhuis Leiden, Leids Universitair Medisch Centrum (LUMC)

Conditions

Acute traumatic painHealthy volunteershealthy subjectshealthy subjects onlyhealthy volunteersnoneopioid use disorder

Phase 2

Comparison of multiple doses of intramuscular versus intranasal naloxone for reversal of opioid toxicity

CompletedCTIS2023-505338-93-00

Leiden University Medical CenterHealthy volunteers

Start: 2023-09-21End: 2024-09-06Target: 22Updated: 2023-08-14

Phase 3

L-NAC for reversal of opioid-induced respiratory depression

CompletedCTIS2023-503912-34-00

Leiden University Medical Centerhealthy subjects only, none

Start: 2023-07-19End: 2024-09-09Target: 18Updated: 2024-04-22

Fentanyl or esketamine for traumatic pain trial

RecruitingCTIS2022-500176-63-00

Amsterdam UMCAcute traumatic pain

Start: 2025-05-20Target: 447Updated: 2025-08-29

Fentanyl effect on ventilatory pattern under sham postsurgical conditions – an exploratory study in healthy men and women – the FAME study

CompletedCTIS2023-508915-22-00

Academisch Ziekenhuis Leidenhealthy subjects, none

Start: 2024-03-04End: 2024-04-26Target: 12Updated: 2024-01-15

Phase 4

(ROAR) Reversal of opioid-induced respiratory depression with opioid antagonists - a pharmacokinetic pharmacodynamic modeling study in opioid naïve individuals and chronic opioid users under real-life conditions

RecruitingCTIS2024-518041-16-00

Leids Universitair Medisch Centrum (LUMC)healthy volunteers, opioid use disorder

Start: 2022-06-15Target: 24Updated: 2024-11-15

Related Papers

P11 Interim results of the fentanyl or esketamine for traumatic pain (FORE-PAIN) trial: a double-blind multi-arm randomized non-inferiority trial

BMJ Military Health2025-10-01

A comparison of intramuscular (Zimhi) and intranasal naloxone (Narcan) in reversal of fentanyl-induced apnea: a randomized, crossover, open-label trial

Nature Communications2025-05-196 citations