None listed
Conditions
Brief summary
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.
Interventions
Participants will receive all three of the following treatments during the experimental period:
IV Ketamine infusion (low dose, Step 1), comprising 8mg/hour IV infusion
Plus initial (one-off) 30mg bolus of ketamine solution. The one-off bolus is administered at the beginning of the infusion.
IV Ketamine infusion (medium dose, Step 2), comprising 12mg/hour IV infusion
IV Ketamine infusion (high dose, Step 3), comprising 20mg/hour IV infusion.
All infusions are timed for one hour. A five mi
Participants will receive all three of the following treatments during the experimental period: IV Ketamine infusion (low dose, Step 1), comprising 8mg/hour IV infusion Plus initial (one-off) 30mg bolus of ketamine solution. The one-off bolus is administered at the beginning of the infusion. IV Ketamine infusion (medium dose, Step 2), comprising 12mg/hour IV infusion IV Ketamine infusion (high dose, Step 3), comprising 20mg/hour IV infusion. All infusions are timed for one hour. A five minute gap is timed between infusion steps. Adherence is monitored by electronically-timed infusion.
Sponsors
Monash Medical Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 45 Years
Healthy volunteers
Yes
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.
Outcome results
None listed