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Recruiting NCT06686914

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

Phase I Interventional Cannabidiol Effects Driving Performance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cannabidiol (CBD) Oil 300mg, Cannabidiol (CBD) Oil 150mg, Placebo Oil.
Who it may be relevant to
Registry conditions: Cannabidiol Effects, Driving Performance. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Cannabidiol (CBD) Oil 300mg
    Cannabidiol (CBD) Oil 300mg, 1 dose
  • Drug Cannabidiol (CBD) Oil 150mg
    Cannabidiol (CBD) Oil 150mg, 1 dose
  • Drug Placebo Oil
    Placebo Oil, 1 dose

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Self-reported sleepiness scale [Time frame: baseline]
  • Self-reported sleepiness scale [Time frame: 200 minutes post intervention]
  • Mental sedation score [Time frame: baseline]
  • Mental sedation score [Time frame: 200 minutes post intervention]
  • Physical sedation score [Time frame: baseline]
  • Physical sedation score [Time frame: 200 minutes post intervention]
  • Mean reaction time to stimuli for PVT [Time frame: baseline]
  • Mean reaction time to stimuli for PVT [Time frame: 200 minutes post intervention]
  • Number of lapses in attention for PVT [Time frame: Baseline]
  • Number of lapses in attention for PVT [Time frame: 200 minutes post intervention]
  • Mean lapse duration for PVT [Time frame: Baseline]
  • Mean lapse duration for PVT [Time frame: 200 minutes post intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • West Virginia University — Morgantown

Identifiers

NCT: NCT06686914 · 2311874160 · 1R01DA058678-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗