None listed
Conditions
Brief summary
Benzodiazepines are common psychoactive medications, used treat to conditions such as anxiety and insomnia, whose therapeutic effects can be accompanied by side effects such as drowsiness and impaired judgment. Observational research suggests an increased risk of road trauma for benzodiazepine and alcohol-affected drivers; however, it is currently legal to drive after consuming legal levels of alcohol and prescribed benzodiazepines, despite the potential risk to road users. This project aims to evaluate the effect of three common benzodiazepines (Alprazolam, Temazepam and Diazepam), in combination with alcohol, on: 1. driving performance, to assess road risk; and 2. eye movements during driving, to identify objective markers of drowsiness and driving impairment. This project will provide vital information regarding the effect of combined benzodiazepine and alcohol use on several physical, cognitive and neurobehavioural indices. This will be achieved through three separate double-blind, placebo-controlled, cross-over trials assessing the direct effect of combined usage of legal levels of alcohol (placebo; 0.04% BAC) and ONE of the three benzodiazepines (placebo; Alprazolam [1mg] OR Temazepam [10mg] OR Diazepam [5mg]). There will be 4 experimental sessions (alcohol + benzodiazepine, alcohol + placebo, placebo + benzodiazepine, and placebo + placebo) involving questionnaires, biological sampling (saliva, blood), cognitive tests, and a driving test on a driving simulator with simultaneous eye monitoring. It is hypothesised that alcohol and benzodiazepines alone and in combination will have an adverse effect on driving performance, and will be marked by specific eye movement patterns.
Interventions
Three separate, double-blind, placebo-controlled cross-over trials will assess the direct effect of combined usage of legal doses of alcohol combined with three commonly used benzodiazepines (Alprazolam, Temazepam and Diazepam).
Each trial will involve four experimental conditions: alcohol (placebo: 0.00% BAC; active: 0.04% BAC) and benzodiazepine drug (placebo; active). The order of the four experimental conditions will be randomised for each participant (placebo-placebo, alcohol active-placeb
Three separate, double-blind, placebo-controlled cross-over trials will assess the direct effect of combined usage of legal doses of alcohol combined with three commonly used benzodiazepines (Alprazolam, Temazepam and Diazepam). Each trial will involve four experimental conditions: alcohol (placebo: 0.00% BAC; active: 0.04% BAC) and benzodiazepine drug (placebo; active). The order of the four experimental conditions will be randomised for each participant (placebo-placebo, alcohol active-placebo, alcohol active-drug active, placebo-drug active). There will be a washout period of at least one week between each experimental condition. Participants will be randomised into one of the three benzodiazepine trials (Trial 1: Alprazolam [1mg], Trial 2: Temazepam [10mg], Trial 3: Diazepam [5mg]). At each visit, participants will be provided a beverage of orange juice and vodka (alcohol active, 0.04% BAC) or orange juice only (placebo) to consume, and a capsule containing a benzodiazepine (drug active) or inactive placebo. Vodka will be administered 0.38g alcohol/kg body weight, the estimated amount of alcohol required to reach a maximum BAC of 0.04%. Adherence to consuming the intervention will be confirmed through direct observation of taking the benzodiazepine capsule and drinking the beverage, as well as the return of an empty beverage cup. Following the treatment, participants will provide blood samples and complete cognitive tasks (CogTrak) at two time-points (30min post-intervention, 2hours post-intervention), a driving test on a driving simulator with simultaneous eye monitoring (50min post-intervention), as well as completing a number of questionnaire relating to subjective state and driving performance.
Sponsors
Swinburne University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
21 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Male or female, aged 21 to 40 years; Willing and able to provide written informed consent; Understands and is willing and able to comply with all study procedures; Fluent in written and spoken English; Must have normal or corrected-to-normal vision; In good general health as judged by the investigator and research nurse; Non-smoker; Social drinker, who is experienced with consuming two alcoholic drinks on a single occasion, typically in a social setting; Experience with benzodiazepines; Is a regular driver (> 4,000 km/year) with three years of driving with a full driver’s licence; Less than 95kg in weight (due to the weight related dosing of alcohol); Willing to abstain from the following prior to their scheduled visit: o No food or drinks (except water) within 2 hours prior to testing o No caffeine-containing products within 12 hours prior to testing o No alcohol within 24 hours prior to testing o No drugs/medication for at least 1 week prior to testing (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne). o No driving or riding a bicycle or motorbike from the site o No driving, riding, operating heavy machinery for 24 hours after leaving the site o No alcohol, drugs, or medication (unless you have consulted with your doctor) for 24 hours after leaving the site
Exclusion criteria
Unable to understand or comply with testing procedures; Inability to speak or read English; History of drug or substance abuse or current illicit drug abuse; History of neurological conditions or previous or current history of psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders; Pregnant, potentially pregnant or lactating; Taking any form of ongoing medication (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne); Unable to participate in scheduled visit, treatment plan, tests and other study procedures according to the protocol; Current participation in any other studies involving investigational or marketed products within 30 days prior to the screening visit; Have previously participated in this study.
Outcome results
None listed