Do cannabidiol and diazepam interact? A proof-of-concept clinical trial.

Phase 2

• Conditions: Anxiety; Mental Health - Anxiety; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12624001021561
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-22
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

a) Between 21–35 years of age.
b) Holds (and has held for at least 1 year) a full (unrestricted) driver’s licence.
c) Proficient in English (i.e., able to provide informed consent).

Exclusion Criteria

a) An ‘active’ (i.e., uncontrolled, symptomatic) physical or mental health condition.
b) Self-reported use of cannabinoids or benzodiazepines within the last 3 months or a positive point-of-care urine drug screen for cannabinoids or benzodiazepines.
c) A self-reported history of allergic reaction (e.g., rhinitis, urticaria, contact dermatitis, anaphylaxis) to cannabinoid- or benzodiazepine-containing products.
d) A self-reported history of liver disease, renal disease, respiratory disease (including sleep apnoea), or drug/alcohol dependence (excluding nicotine dependence).
e) A suspected drug/alcohol dependence (excluding nicotine dependence).
f) A self-reported neurological disorder or intellectual disability.
g) Self-reported or suspected suicidal ideation.
h) A body weight <50 kg or body mass index >30 kg/m2.
i) Regular (i.e., weekly, or more often) use of medications or herbal remedies that induce or inhibit the cytochrome P450 (CYP) enzyme system or are metabolised by CYP enzymes that are inhibited by CBD (e.g., CYP2C19, CYP3A4).
j) Carrying one or more non-functional CYP2C19 alleles (i.e., *2 or *3).
k) Frequent (i.e., more than thrice weekly) use of psychoactive substances (excluding caffeine).
l) Unwilling or unable to adhere to trial procedures.
m) Pregnant, lactating or trying to conceive a child.

Study & Design

• Study Type: Interventional
• Study Design: Not specified