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

NCT ID: NCT06686914

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2029-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cannabidiol Effects Driving Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Cannabidiol (CBD) Oil 150mg

Intervention Type DRUG

Cannabidiol (CBD) Oil 150mg, 1 dose

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).

Group Type PLACEBO_COMPARATOR

Placebo Oil

Intervention Type DRUG

Placebo Oil, 1 dose

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).

Group Type ACTIVE_COMPARATOR

Cannabidiol (CBD) Oil 300mg

Intervention Type DRUG

Cannabidiol (CBD) Oil 300mg, 1 dose

Interventions

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Cannabidiol (CBD) Oil 300mg

Cannabidiol (CBD) Oil 300mg, 1 dose

Intervention Type DRUG

Cannabidiol (CBD) Oil 150mg

Cannabidiol (CBD) Oil 150mg, 1 dose

Intervention Type DRUG

Placebo Oil

Placebo Oil, 1 dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

West Virginia University

OTHER

Sponsor Role lead

Responsible Party

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Toni Marie Rudisill

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Toni M Rudisill, PhD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

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West Virginia University

Morgantown, West Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Toni M Rudisill, PhD

Role: CONTACT

3042930687

Facility Contacts

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Toni M Rudisill, PhD

Role: primary

304-293-0687

Other Identifiers

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1R01DA058678-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2311874160

Identifier Type: -

Identifier Source: org_study_id

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