Clinical trial NCT06686914: The Effects of Cannabidiol on the Driving Performance of Healthy Adults by Dose and Sex
Official title: The Effects of Cannabidiol on the Driving Performance of Healthy Adults by Dose and Sex
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cannabidiol Effects
Driving Performance
Lead sponsor: West Virginia University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-11-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Mean standard deviation of lateral position
timeFrame: 150 minutes post intervention
measure: Number of collisions
timeFrame: 150 minutes post intervention
measure: Mean reaction time to stimuli
timeFrame: 150 minutes post intervention
measure: Percent of time driver is out of travel lane
timeFrame: 150 minutes post intervention
Secondary outcomes:
measure: Self-reported sleepiness scale
timeFrame: baseline
measure: Self-reported sleepiness scale
timeFrame: 200 minutes post intervention
measure: Mental sedation score
timeFrame: baseline
measure: Mental sedation score
timeFrame: 200 minutes post intervention
measure: Physical sedation score
timeFrame: baseline
measure: Physical sedation score
timeFrame: 200 minutes post intervention
measure: Mean reaction time to stimuli for PVT
timeFrame: baseline
measure: Mean reaction time to stimuli for PVT
timeFrame: 200 minutes post intervention
measure: Number of lapses in attention for PVT
timeFrame: Baseline
measure: Number of lapses in attention for PVT
timeFrame: 200 minutes post intervention
measure: Mean lapse duration for PVT
timeFrame: Baseline
measure: Mean lapse duration for PVT
timeFrame: 200 minutes post intervention
measure: Number of errors for PVT
timeFrame: Baseline
measure: Number of errors for PVT
timeFrame: 200 minutes post intervention
measure: Interference score for mean reaction on FT
timeFrame: Baseline
measure: Interference score for mean reaction on FT
timeFrame: 200 minutes post intervention
measure: Interference score for accuracy on FT
timeFrame: Baseline
measure: Interference score for accuracy on FT
timeFrame: 200 minutes post intervention
measure: Time to accurately complete the Trail Making Test Part A
timeFrame: Baseline
measure: Time to accurately complete the Trail Making Test Part A
timeFrame: 200 minutes post intervention
measure: Time to accurately complete the Trail Making Test Part B
timeFrame: Baseline
measure: Time to accurately complete the Trail Making Test Part B
timeFrame: 200 minutes post intervention
measure: Total recalled words on the Hopkins Verbal Learning test
timeFrame: Baseline
measure: Total recalled words on the Hopkins Verbal Learning test
timeFrame: 200 minutes post intervention
measure: Discrimination index for the Hopkins Verbal Learning test
timeFrame: Baseline
measure: Discrimination index for the Hopkins Verbal Learning test
timeFrame: 200 minutes post intervention
measure: Percentage correctness of response on Stroop Test
timeFrame: Baseline
measure: Percentage correctness of response on Stroop Test
timeFrame: 200 minutes post intervention
measure: Number congruent responses on Stroop Test
timeFrame: Baseline
measure: Number congruent responses on Stroop Test
timeFrame: 200 minutes post intervention
measure: Number incongruent responses on Stroop Test
timeFrame: Baseline
measure: Number incongruent responses on Stroop Test
timeFrame: 200 minutes post intervention
measure: Sum of scores for forward and backward responses on Digit Span test
timeFrame: Baseline
measure: Sum of scores for forward and backward responses on Digit Span test
timeFrame: 200 minutes post intervention
measure: Gestalt score based on correctness of clock drawing
timeFrame: Baseline
measure: Gestalt score based on correctness of clock drawing
timeFrame: 200 minutes post intervention
measure: Number of correct and non-duplicate responses on Animal Naming test
timeFrame: Baseline
measure: Number of correct and non-duplicate responses on Animal Naming test
timeFrame: 200 minutes post intervention
measure: Number of omission errors on N-back test
timeFrame: Baseline
measure: Number of omission errors on N-back test
timeFrame: 200 minutes post intervention
measure: Number of commission errors on N-Back test
timeFrame: Baseline
measure: Number of commission errors on N-Back test
timeFrame: 200 minutes post intervention
measure: Percent correct matches on N-Back test
timeFrame: Baseline
measure: Percent correct matches on N-Back test
timeFrame: 200 minutes post intervention
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Toni M Rudisill, PhD
role: PRINCIPAL_INVESTIGATOR
References: