This open-label Phase I trial (n=20) evaluated the safety and efficacy of ketamine for drugged driving.
The clinical utility of ketamine as demonstrated efficacy as a novel antidepressant and anti-anxiolytic, as well as a low-risk, effective tool to manage chronic pain among treatment resistant patients. Perhaps paradoxically, however, the associated cognitive, behavioural and attention impairments pose significant implications for driving ability and road safety. Despite this, no studies are currently available which explicitly assess the effect of sub-anaesthetic doses of ketamine on several facets of neurocognitive functioning related to driving performance, as well as explicit assessments of driving impairment.
This study aims to assess the effect of three doses of intravenously (IV) administered ketamine infusions delivered in an increasing step-dose manner on measures of higher-order cognitive processes and driving simulator performance. We will also assess the relatedness between the level of ketamine in the blood samples and over the 8 hour testing session in order to assess the relationship between ketamine blood concentration, cognitive function and driving ability. We also want to monitor the relationship between the treatment (ketamine infusion low, medium or high dose) and levels of subjective alertness over time, and how this relates to performance outcomes on the cognitive and driving tasks.