The Effect of Three Stepwise Doses of Intravenously Administered Ketamine Infusions on Cognitive Functioning and Simulated Driving Performance.
This open-label Phase I trial (n=20) evaluated the safety and efficacy of ketamine for drugged driving.
Detailed Description
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.
Study Arms & Interventions
Experimental Arm
experimentalInterventions
- Ketamine
Participants
Inclusion Criteria
- Aged between 21 and 45 years.
- Hold a full drivers licence (no ‘P’ plates).
- No known allergic reaction to ketamine or other related opioids.
- Have no history of past substance abuse or current abuse of illicit drugs.
- Have no pre-existing physical or neurological conditions, no previous or current history of severe psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders.
- Not currently pregnant or lactating
Exclusion Criteria
- Inability to speak or read English.
- Taking any form of medication within 5 days of admission (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study.
- Unable to participate in scheduled visit, treatment plan, tests and other trial procedures according to the protocol.
- Current participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit.
Study Details
- StatusCompleted
- PhasePhase I
- Typeinterventional
- DesignRandomized
- Target Enrollment20 participants
- TimelineStart: 2016-09-22End: 2016-11-16
- Compound