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

NCT06686914 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 23118741601R01DA058678-01A1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cannabidiol Effects; Driving Performance

Outcome Measures

Primary Outcomes (4)

• Mean standard deviation of lateral position

  The driving simulator will measure mean standard deviation which is the amount a driver is weaving within the lane during the drive. Ranges from 0 to infinity, with higher means indicating worse performance.

  150 minutes post intervention

• Number of collisions

  The driving simulator will measure how many times a participant crashes into other vehicles, signs, pedestrians, etc. during the simulation. Ranges from 0 to infinity, with higher numbers indicating worse performance.

  150 minutes post intervention

• Mean reaction time to stimuli

  The driving simulator will measure the mean reaction time (seconds) that it takes for a person to brake when exposed to stimuli. Ranges from 0 to infinity, with higher means indicating worse performance.

  150 minutes post intervention

• Percent of time driver is out of travel lane

  The driving simulator will measure the percent of time that each driver spends driving outside their travel lane. Percent ranges from 0-100, with higher scores indicating worse performance.

  150 minutes post intervention

Secondary Outcomes (44)

• Self-reported sleepiness scale

  baseline

• Self-reported sleepiness scale

  200 minutes post intervention

• Mental sedation score

  baseline

• Mental sedation score

  200 minutes post intervention

• Physical sedation score

  baseline

Study Arms (3)

Cannabidiol (CBD) Oil 300mg

ACTIVE COMPARATOR

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).

Drug: Cannabidiol (CBD) Oil 300mg

Cannabidiol (CBD) Oil 150mg

ACTIVE COMPARATOR

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).

Drug: Cannabidiol (CBD) Oil 150mg

Placebo Oil

PLACEBO COMPARATOR

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).

Drug: Placebo Oil

Interventions

Cannabidiol (CBD) Oil 300mg DRUG

Cannabidiol (CBD) Oil 300mg, 1 dose

Cannabidiol (CBD) Oil 300mg

Cannabidiol (CBD) Oil 150mg DRUG

Cannabidiol (CBD) Oil 150mg, 1 dose

Cannabidiol (CBD) Oil 150mg

Placebo Oil DRUG

Placebo Oil, 1 dose

Placebo Oil

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Interventions

Cannabidiol; Oils

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Lipids

Study Officials

• Toni M Rudisill, PhD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Toni M Rudisill, PhD

CONTACT

3042930687; trudisill@hsc.wvu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 13, 2024
• Study Start: June 30, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

US (1)