A randomized, multicenter trial assessing the effects of rapastinel compared to ketamine, alprazolam, and placebo on simulated driving performance

Su, Sheng‐Fang; Kay, Gary G.; Hochadel, Thomas J.; Rojo, Jonathan; Stein, John C.; Boinpally, Ramesh; Periclou, Antonia

doi:10.1111/cts.13145

Cited by 3 publications

(13 citation statements)

References 29 publications

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“…Ketamine use is known to affect the necessary skills needed for the safe operation of a vehicle; for example, longer reaction times in certain tasks and impairment of different neurocognitive and psychomotor functions are seen [ 44 ]. Driving requires functioning in multiple domains of cognition and sensation, including visual tracking, attention, and time perception [ 45 ]. Ketamine has been shown to affect each of these individual domains.…”

Section: Clinical Studies On Ketamine-impaired Drivingmentioning

confidence: 99%

“…Ketamine has been shown to affect each of these individual domains. It has been detected in 45% of intoxicated drivers who were involved in non-fatal accidents and 9% of intoxicated drivers who were involved in fatal accidents in Hong Kong [ 45 ].…”

Section: Clinical Studies On Ketamine-impaired Drivingmentioning

confidence: 99%

“…Another study evaluated the driving performance of healthy participants after a single dose of rapastinel (an NMDA ionotropic glutaminergic receptor modulator) compared to ketamine (also an NMDA ionotropic glutaminergic receptor modulator) and placebo groups on simulated driving performance [ 45 ]. The study was a phase I, randomized, multicenter, placebo-controlled, five-period, crossover, single-dose study that evaluated the driving performance of 107 individuals 45 min after single doses of IV bolus rapastinel (900 and 1800 mg), alprazolam, ketamine, or the placebo.…”

Section: Clinical Studies On Ketamine-impaired Drivingmentioning

confidence: 99%

“…Participants were prohibited from using concomitant medications (except progesterone only, birth control, or hormone replacement therapy). The study was conducted in two study centers in the United States and Canada, and the primary endpoint was the standard deviation of lateral position (SDLP) during a 100-km 60-min simulated driving scenario after a single IV dose of rapastinel 900 mg and 1800 mg compared to placebo and alprazolam 0.75 mg [ 45 ]. Additional secondary endpoints included other measures of driving performance, the CogScreen SDC test, and self-reported measures [ 45 ].…”

Section: Clinical Studies On Ketamine-impaired Drivingmentioning

confidence: 99%

“…Self-reported measures included self-rating safety to drive, motivation and driving performance, and sleepiness. Sleepiness was measured with the Karolinska Sleepiness Scale [ 45 ]. Of the 107 participants, 97 completed the study (90.7%) [ 45 ].…”

Section: Clinical Studies On Ketamine-impaired Drivingmentioning

confidence: 99%

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Ketamine Evolving Clinical Roles and Potential Effects with Cognitive, Motor and Driving Ability

Edinoff

Sall

Koontz

et al. 2023

Neurology International

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While driving under the influence of drugs, drivers are more likely to be involved in and cause more accidents than drivers who do not drive under the influence. Ketamine is derived from phencyclidine and acts as a noncompetitive antagonist and allosteric modulator of N-methyl-D-aspartate receptors. Ketamine has been used to treat a variety of psychiatric disorders, with the most notable being treatment-resistant depression. With the rise of at-home ketamine treatment companies, the safety of unsupervised administration remains under evaluation. A study with ketamine and a ketamine-like medication, rapasitnel, showed that those who were given ketamine experienced more sleepiness and had decreased self-reported motivation and confidence in their driving abilities. Moreover, there seem to be significant differences in the acute versus persistent effects of ketamine, as well as the anesthetic versus subanesthetic doses, both in terms of effects and outcomes. These divergent effects complicate the clinical uses of ketamine, specifically involving driving, drowsiness, and cognitive abilities. This review aims to describe not only the various clinical uses of ketamine but also the potentially detrimental effects of driving under the influence, which should be understood to help with counseling the patients who use these substances, both for their well-being and to protect public safety.

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Section: Clinical Studies On Ketamine-impaired Drivingmentioning

confidence: 99%

Section: Clinical Studies On Ketamine-impaired Drivingmentioning

confidence: 99%

Section: Clinical Studies On Ketamine-impaired Drivingmentioning

confidence: 99%

Section: Clinical Studies On Ketamine-impaired Drivingmentioning

confidence: 99%

Section: Clinical Studies On Ketamine-impaired Drivingmentioning

confidence: 99%

See 3 more Smart Citations

Ketamine Evolving Clinical Roles and Potential Effects with Cognitive, Motor and Driving Ability

Edinoff

Sall

Koontz

et al. 2023

Neurology International

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A randomized, multicenter trial assessing the effects of rapastinel compared to ketamine, alprazolam, and placebo on simulated driving performance

Kay

Hochadel

et al. 2021

Clinical Translational Sci

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Combination administration of alprazolam and N-Ethylmaleimide synergistically enhances sleep behaviors in mice with no potential CNS side effects

Zhu,

Shi,

Zhang

et al. 2024

PeerJ

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Background N-Ethylmaleimide (NEM), an agonist of the potassium chloride cotransporters 2 (KCC2) receptor, has been correlated with neurosuppressive outcomes, including decreased pain perception and the prevention of epileptic seizures. Nevertheless, its relationship with sleep-inducing effects remains unreported. Objective The present study aimed to investigate the potential enhancement of NEM on the sleep-inducing properties of alprazolam (Alp). Methods The test of the righting reflex was used to identify the appropriate concentrations of Alp and NEM for inducing sleep-promoting effects in mice. Total sleep duration and sleep quality were evaluated through EEG/EMG analysis. The neural mechanism underlying the sleep-promoting effect was examined through c-fos immunoreactivity in the brain using immunofluorescence. Furthermore, potential CNS-side effects of the combination Alp and NEM were assessed using LABORAS automated home-cage behavioral phenotyping. Results Combination administration of Alp (1.84 mg/kg) and NEM (1.0 mg/kg) significantly decreased sleep latency and increased sleep duration in comparison to administering 1.84 mg/kg Alp alone. This effect was characterized by a notable increase in REM duration. The findings from c-fos immunoreactivity indicated that NEM significantly suppressed neuron activation in brain regions associated with wakefulness. Additionally, combination administration of Alp and NEM showed no effects on mouse neural behaviors during automated home cage monitoring. Conclusions This study is the first to propose and demonstrate a combination therapy involving Alp and NEM that not only enhances the hypnotic effect but also mitigates potential CNS side effects, suggesting its potential application in treating insomnia.

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A randomized, multicenter trial assessing the effects of rapastinel compared to ketamine, alprazolam, and placebo on simulated driving performance

Abstract: This is an open access article under the terms of the Creat ive Commo ns Attri bution-NonCo mmercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

Cited by 3 publications

References 29 publications

Ketamine Evolving Clinical Roles and Potential Effects with Cognitive, Motor and Driving Ability

Ketamine Evolving Clinical Roles and Potential Effects with Cognitive, Motor and Driving Ability

A randomized, multicenter trial assessing the effects of rapastinel compared to ketamine, alprazolam, and placebo on simulated driving performance

Combination administration of alprazolam and N-Ethylmaleimide synergistically enhances sleep behaviors in mice with no potential CNS side effects

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