ACTRN12623001255673
Recruiting
Phase 2
A randomised, placebo-controlled crossover trial examining the biphasic effects of alcohol on ocular parameters during driving in adults who drive regularly (ALC-GAZE)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- eurological
- Sponsor
- Swinburne University of Technology
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, aged 21 to 55 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
- •\- Previous history of alcohol consumption in a single drinking session to an estimated BAC of 0\.05% with no known adverse reaction \[more than 3 standard drinks (female) or 4 standard drinks (male) on single drinking occasion]
- •\- Normal or corrected\-to\-normal vision
- •\- Regular driver (\>50km/week) with three years of driving with a full Australian or International driver’s licence (no ‘P\-Plate’ drivers)
- •\- Weight under 100kg. This limit is critical for participant safety. In this study, alcohol delivery is based on weight, and by defining this limit, we avoid overdosing and hence minimise potential health concerns
- •\- Willing to abstain from the following prior to their scheduled visit:
- •\- No food or drinks (except water) within 2 hours prior to testing
Exclusion Criteria
- •\- Unable to understand or comply with testing procedures
- •\- Inability to speak or read English
- •\- History of drug abuse or dependence or current illicit drug abuse
- •\- Current neurological, psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders
- •\- Pregnant or lactating
- •\- Taking any form of medication within one week 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 study procedures according to the protocol
- •\- Weight over 100kg
- •\- Moderate\-severe current depression (BDI score of greater than or equal to 20\)
- •\- Severe current anxiety (BAI score greater than or equal to 16\)
Outcomes
Primary Outcomes
Not specified
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