Recruiting
Phase 1

Cannabidiol

Sponsor:

West Virginia University

Code:

NCT06686914

Conditions

Cannabidiol Effects

Driving Performance

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Interventions

Cannabidiol (CBD) Oil 300mg

Cannabidiol (CBD) Oil 150mg

Placebo Oil

Study Details

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

Study ID

NCT06686914

Start date

Jun 30, 2025

Status verified date

Oct, 2025

Completion date

May 1, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Cannabidiol (CBD) Oil 300mg

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).

active comparator: Cannabidiol (CBD) Oil 150mg

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).

placebo comparator: Placebo Oil

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).

Interventions

Cannabidiol (CBD) Oil 300mg

Cannabidiol (CBD) Oil 300mg, 1 dose

Cannabidiol (CBD) Oil 150mg

Cannabidiol (CBD) Oil 150mg, 1 dose

Placebo Oil

Placebo Oil, 1 dose

Primary outcome measure

  • Mean standard deviation of lateral position [ Time Frame: 150 minutes post intervention ]
  • Number of collisions [ Time Frame: 150 minutes post intervention ]
  • Mean reaction time to stimuli [ Time Frame: 150 minutes post intervention ]
  • Percent of time driver is out of travel lane [ Time Frame: 150 minutes post intervention ]

Central Contacts and Locations

Central contacts

Toni M Rudisill, PhD

3042930687trudisill@hsc.wvu.edu

Locations

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Toni M Rudisill, PhD

304-293-0687trudisill@hsc.wvu.edu

Principal Investigator:

Toni M Rudisill, PhD

More Information

Sponsor

West Virginia University

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by West Virginia University on 2025-10-31.