The Effects of Cannabidiol on the Driving Performance of Healthy Adults by Dose and Sex

West Virginia University

Status and phase: Enrolling; Phase 1

Conditions: Driving Performance; Cannabidiol Effects

Treatments: Drug: Cannabidiol (CBD) Oil 300mg; Drug: Cannabidiol (CBD) Oil 150mg; Drug: Placebo Oil

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06686914

2311874160

1R01DA058678-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The objectives/purpose of this study are to comprehensively investigate the effects of non-prescription CBD on driving performance, drowsiness, sedation, and cognitive function in a large sample of healthy adults aged 18-30 years, with additional characterization of effects by dose and by sex, using a rigorous RCT design which will naturally mitigate confounding factors.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Possess a current drivers' license
• Driven a motor vehicle at least once in the past 30 days
• Able to read English
• Test negative for all substances on a urine drug test and complete a test drive to ensure the absence of simulation sickness
• Not taking any daily prescription medications (excluding birth control)
• Not diagnosed with any serious chronic disease by a licensed healthcare provider (including but not limited to Alzheimer's and related dementias, Parkinson's disease or other neurodegenerative disorder, major depressive or anxiety disorder, schizophrenia or other serious mental illness, arrhythmias, cataracts, glaucoma, chronic obstructive pulmonary disease, diabetes, epilepsy, sleep apnea, and fibromyalgia)
• Have an individual willing to drive them home after testing or be taken home by study staff after testing

Exclusion criteria

• Currently smoke, vape or use tobacco products, used CBD in the past 30 days
• Used illegal drugs in the past 30 days (e.g., cocaine/crack, heroin, methamphetamine, 3,4-methylenedioxy-methamphetamine, inhalants, phencyclidine, lysergic acid diethylamide, psilocybin mushrooms, or marijuana)
• Are pregnant or lactating at time of study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 3 patient groups, including a placebo group

Cannabidiol (CBD) Oil 300mg

Active Comparator group

Description:

Cannabidiol (CBD) Oil, 300mg, 1 dose, 120 minutes prior to testing. After consumption of the respective treatment drug, the participant will be given a standardized meal and wait for 120 minutes to allow for drug absorption and for CBD to begin taking effect; this time frame was chosen based on the pharmacokinetics of CBD along with the consideration of participant burden (max absorption 2-5 hours; average half-life 17 hours).

Treatment:

Drug: Cannabidiol (CBD) Oil 300mg

Cannabidiol (CBD) Oil 150mg

Active Comparator group

Description:

Cannabidiol (CBD) Oil, 150mg, 1 dose, 120 minutes prior to testing. After consumption of the respective treatment drug, the participant will be given a standardized meal and wait for 120 minutes to allow for drug absorption and for CBD to begin taking effect; this time frame was chosen based on the pharmacokinetics of CBD along with the consideration of participant burden (max absorption 2-5 hours; average half-life 17 hours).

Treatment:

Drug: Cannabidiol (CBD) Oil 150mg

Placebo Oil

Placebo Comparator group

Description:

Placebo Oil 1 dose 120 minutes prior to testing. After consumption of the respective treatment drug/placebo, the participant will be given a standardized meal and wait for 120 minutes to allow for drug absorption and for CBD to begin taking effect; this time frame was chosen based on the pharmacokinetics of CBD along with the consideration of participant burden (max absorption 2-5 hours; average half-life 17 hours).

Treatment:

Drug: Placebo Oil