Intranasal Naloxone Repeat Dosing Strategies and Fentanyl Overdose: A Simulation-Based Randomized Clinical Trial
Authors' conclusion
In this clinical trial with healthy participants, compared with 1 intranasal naloxone dose administered at 0 and 2.5 minutes, 1 dose at 0, 2.5, 5, and 7.5 minutes significantly increased naloxone plasma concentration at 10 minutes, whereas 2 doses at 0 and 2.5 minutes significantly increased naloxone plasma concentration at 4.5 minutes.
Study context
- Population
- Healthy nonsmoking adults aged 18 to 55 years with negative alcohol and drug tests18 (86%) completed
- Participants
- 21 participants
- Comparison
- Intranasal naloxone repeat dosing: 1 dose at 0, 2.5, 5, 7.5 min or 2 doses at 0 and 2.5 min vs 1 dose at 0 and 2.5 min
- Primary endpoint
- First prespecified time with higher naloxone plasma concentration
Methodological detailsunblinded, crossover, single-centre clinical pharmacology unit, Clinical pharmacology unit (Spaulding Clinical Research, West Bend, Wisconsin), March 2021
- Unblinded
- Crossover
- Single-centre clinical pharmacology unit
- Clinical pharmacology unit (Spaulding Clinical Research, West Bend, Wisconsin), March 2021
Primary result
As reported in the abstract
Naloxone plasma concentration
Each group vs 1 dose at 0 and 2.5 minutesGeometric mean ratio (97.8% one-sided CI)
1 dose at 0, 2.5, 5, and 7.5 minutesat 10 minutes; 1-sided CI
1.95(1.28-∞)
2 doses at 0 and 2.5 minutesat 4.5 minutes; 1-sided CI
1.98(1.03-∞)
Secondary outcomes
Estimated brain hypoxia time after simulated fentanyl 2.97-mg IV bolus (PK-PD model) · descriptive statistics
Safety
- No drug-related serious adverse events reported
Original publication
Intranasal Naloxone Repeat Dosing Strategies and Fentanyl Overdose: A Simulation-Based Randomized Clinical Trial. JAMA Netw Open. Published 2 January 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →