The effect of cannabidiol (CBD) on simulated driving performance.

Phase 2

Completed

• Conditions: Road Trauma; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12619001552178
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-11
• Study Completion: 2021-01-20
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

(a)Between 18 and 65 years of age;
(b)No reported use of cannabis within the past 3 months; to be confirmed by a negative urine drug screen at the medical screening;
(c)In possession of full (unrestricted) Australian driver’s license for at least 1 y;
(d)Proficient in English (i.e. must not require an English translator).

Exclusion Criteria

(a)Cannabis dependence or any other drug or alcohol dependence, as per the International Statistical Classification of Diseases 10th Revision criteria or at the medical officer’s discretion;
(b)Contraindications to cannabinoids, including clinically significant prior adverse response to cannabis, cannabinoid products or synthetic cannabinoids (e.g. panic, anxiety attacks, arrhythmia, falls, seizures or other);
(c)History of a major psychiatric disorder within the previous 12 months (except clinically managed mild depression) as per the Diagnostic and Statistical Manual of Mental Disorders-V criteria or at the medical officer’s discretion;
(d)History of attempted suicide or current suicide ideation as determined by a score >0 on Question 9 of the Patient Health Questionnaire-9;
(e)A diagnosed sleep disorder, as per the International Classification of Sleep Disorders Diagnostic and Coding manual or at the medical officer’s discretion;
(f)Pregnant or lactating. All female volunteers of childbearing potential will be required to complete a human chorionic gonadotrophin (hCG) urine screen to rule out pregnancy at the medical screening; females of childbearing potential and males with a female partner must agree to use a reliable form of contraception during and one month following their participation in this project;
(g)Inability to refrain from alcohol consumption 24 h prior to each experimental trial;
(h)Inability to refrain from using other central nervous system active drugs (e.g. opioids, benzodiazepines) while participating in this project;
(i)Use of medications that may influence CBD metabolism, such as inducers or inhibitors of the CYP450 enzyme system;
(j)Use of medications handled by transporter proteins or CYP enzymes that are inhibited by CBD, such as anticoagulants, calcium channel blockers, beta-blockers and sulfonylureas;
(k)Use of anticonvulsive medications, such as clobazam or valproate;
(l)Required to complete mandatory drug testing for cannabis (e.g. workplace testing; court order);
(m)A high habitual caffeine (i.e. >300 mg·d-1);
(n)At risk for developing driving simulator sickness, as determined at the medical screening using the Simulator Sickness Questionnaire;
(o)Body mass index (BMI) >30 kg·m2

Study & Design

• Study Type: Interventional
• Study Design: Not specified