Cannabidiol for Driving Performance

Overseen By Toni M Rudisill, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: West Virginia University

Must not be taking: Daily prescriptions

Disqualifiers: Tobacco, Illegal drugs, Pregnancy, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

Yes, you must not be taking any daily prescription medications, except for birth control, to participate in this trial.

Is cannabidiol (CBD) generally safe for human use?

CBD is generally considered safe, but some studies have reported adverse effects, particularly neurological and developmental issues. Serious adverse reactions have been noted, especially when used with other medications like antiepileptics, and more research is needed to fully understand its safety profile. ^{1 2 3 4 5}

How does the drug Cannabidiol (CBD) differ from other treatments for driving performance?

Cannabidiol (CBD) is unique because it does not cause cognitive or psychomotor impairment like THC, the psychoactive component of cannabis, making it potentially safer for activities like driving. Unlike other treatments, CBD is a non-intoxicating component of cannabis and can be administered through various routes such as inhalation, ingestion, or skin application. ^{4 6 7 8 9}

Research Team

Toni M Rudisill, PhD

Principal Investigator

West Virginia University

Eligibility Criteria

This clinical trial is for healthy adults aged 18-30 who want to help study the effects of CBD on driving. Participants should not be taking any medications or substances that could affect their driving, and they must have a valid driver's license.

Inclusion Criteria

Possess a current drivers' license

I have driven a car in the last 30 days.

Able to read English

Exclusion Criteria

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)

Currently smoke, vape or use tobacco products, used CBD in the past 30 days

Are pregnant or lactating at time of study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of either 300mg or 150mg of Cannabidiol (CBD) Oil or a placebo, followed by a standardized meal and a waiting period for drug absorption

1 day

1 visit (in-person)

Testing

Participants undergo driving performance tests and cognitive assessments 120 minutes post-intervention

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any adverse effects and overall safety after the testing phase

1-2 weeks

Treatment Details

Interventions

• Cannabidiol

Trial Overview The trial is testing how different doses of CBD oil (150mg and 300mg) versus a placebo oil impact driving performance, alertness, and thinking in men and women. It's a carefully controlled study where participants are randomly assigned to one of the treatments.

Participant Groups

Group I: Cannabidiol (CBD) Oil 300mg Active Control 1 Intervention

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 II: Cannabidiol (CBD) Oil 150mg Active Control 1 Intervention

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 III: Placebo Oil Placebo Group 1 Intervention

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).

Cannabidiol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Vaporized THC-dominant and THC/CBD-equivalent cannabis significantly impaired driving performance, as indicated by increased lane weaving (measured by standard deviation of lateral position) compared to placebo, particularly 40 to 100 minutes after consumption.

CBD-dominant cannabis did not show significant impairment compared to placebo, suggesting it may not affect driving ability; however, the study notes that the tested doses may not reflect typical usage patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Cannabidiol and Δ9-Tetrahydrocannabinol on Driving Performance: A Randomized Clinical Trial. Arkell, TR., Vinckenbosch, F., Kevin, RC., et al.[2021]

A systematic review of 51 clinical studies indicates that cannabidiol (CBD) is generally well tolerated in humans, with most adverse events (AEs) being mild to moderate, such as diarrhea and sedation.

While serious AEs are rare, they can occur, particularly when CBD is taken with other medications, highlighting the need for careful monitoring of drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on Cannabidiol Clinical Toxicity and Adverse Effects: A Systematic Review. Madeo, G., Kapoor, A., Giorgetti, R., et al.[2023]

Serious suspected adverse reactions (SARs) to unlicensed cannabidiol (CBD) products were found to be 18.9% of all adverse events, with a higher frequency in men and adults, indicating a need for careful monitoring of its use.

The most common adverse effects associated with unlicensed CBD included mental disorders, hepatic disorders, and worsening of pre-existing epilepsy, particularly in patients also taking antiepileptic medications like clobazam and valproic acid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of unlicensed cannabidiol in European countries. Calapai, F., Esposito, E., Ammendolia, I., et al.[2023]

This study will assess the effects of cannabidiol (CBD) on driving performance and cognitive function in 30 healthy individuals, using a randomized, double-blind, placebo-controlled design to ensure reliable results.

The research aims to determine if CBD causes any impairment in driving, comparing its effects to a placebo, and will also investigate whether CBD could lead to false-positive drug tests for Δ9-THC, ensuring safety for drivers using CBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of cannabidiol on simulated car driving performance: A randomised, double-blind, placebo-controlled, crossover, dose-ranging clinical trial protocol. McCartney, D., Benson, MJ., Suraev, AS., et al.[2021]

A systematic review of 4186 studies on cannabidiol (CBD) revealed that most research focuses on neurological outcomes, with significant adverse events reported in this area, highlighting the need for careful assessment of CBD's safety.

There is a notable gap in research regarding the reproductive and developmental toxicity of CBD, suggesting that future studies should prioritize these areas to establish safe intake levels for consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol Safety Data: A Systematic Mapping Study. Henderson, RG., Franke, KS., Payne, LE., et al.[2023]

In a survey of 239 young adults using cannabis, those who preferred CBD-dominant products were more likely to be female, use cannabis less frequently, and report using it primarily for medical reasons such as pain and psychological issues.

The study found a concerning association between CBD use and increased illicit drug use, suggesting that some individuals may be using CBD as a form of self-medication for underlying psychological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol (CBD) and other drug use among young adults who use cannabis in Los Angeles. Fedorova, EV., Wong, CF., Ataiants, J., et al.[2022]

In a study with 14 healthy volunteers, both THC-dominant and THC/CBD equivalent cannabis impaired driving performance, particularly increasing lane weaving, indicating that both types can negatively affect driving safety.

Interestingly, the THC/CBD equivalent cannabis led to higher peak plasma THC levels and caused greater impairment on certain cognitive tasks compared to THC-dominant cannabis, suggesting that CBD may not mitigate THC's adverse effects and could potentially worsen them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol (CBD) content in vaporized cannabis does not prevent tetrahydrocannabinol (THC)-induced impairment of driving and cognition. Arkell, TR., Lintzeris, N., Kevin, RC., et al.[2022]

In a study involving 74 healthy adult volunteers, vaporization of low-THC, CBD-rich cannabis products did not significantly impair driving-related abilities compared to a placebo, suggesting that these products may be safe for driving.

THC levels in the blood peaked shortly after consumption but dropped below detectable levels within 1.5 hours for most participants, although some still had detectable THC up to 5 hours later, which could have legal implications for drivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of vaporizing cannabis rich in cannabidiol on cannabinoid levels in blood and on driving ability - a randomized clinical trial. Egloff, L., Frei, P., Gerlach, K., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Cannabidiol and Δ9-Tetrahydrocannabinol on Driving Performance: A Randomized Clinical Trial. [2021]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Update on Cannabidiol Clinical Toxicity and Adverse Effects: A Systematic Review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of unlicensed cannabidiol in European countries. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The effect of cannabidiol on simulated car driving performance: A randomised, double-blind, placebo-controlled, crossover, dose-ranging clinical trial protocol. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol Safety Data: A Systematic Mapping Study. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

Cannabidiol (CBD) and other drug use among young adults who use cannabis in Los Angeles. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Cannabidiol (CBD): Analytical and toxicological aspects]. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Cannabidiol (CBD) content in vaporized cannabis does not prevent tetrahydrocannabinol (THC)-induced impairment of driving and cognition. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Effect of vaporizing cannabis rich in cannabidiol on cannabinoid levels in blood and on driving ability - a randomized clinical trial. [2023]