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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how non-prescription CBD (Cannabidiol) affects driving, sleepiness, and cognitive skills. Participants will take either two different doses of CBD or a placebo (a substance with no active ingredients) to assess the impact on their driving ability. The trial suits healthy adults who have a driver's license, have driven recently, and do not regularly take prescription medications (except birth control). Participants should also refrain from using tobacco or CBD and must have someone to drive them home after testing. As a Phase 1 trial, this research focuses on understanding how CBD works in people, offering participants the opportunity to be among the first to receive this treatment.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, researchers found that CBD does not cause a high. It likely does not affect thinking or driving skills, though some individuals might feel sleepy, which is important to consider when driving. Interestingly, after taking CBD, participants showed a slight decrease in car crashes and a small increase in reaction times. This suggests that while CBD has some effects, it appears generally safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using cannabidiol (CBD) for driving performance because it offers a potential new approach to managing related concerns without the psychoactive effects associated with other cannabis compounds like THC. Unlike traditional treatments that might rely on stimulants or sedatives, CBD is a non-intoxicating compound that might help support focus and calmness. The study explores different dosages of CBD oil, 150mg and 300mg, to evaluate its impact on driving abilities, offering a fresh perspective on maintaining safety while potentially benefiting from the calming effects of CBD.

What evidence suggests that this trial's treatments could be effective for driving performance?

This trial will compare the effects of different doses of Cannabidiol (CBD) on driving performance. Studies have shown that CBD does not significantly affect driving ability. Research indicates that people who use CBD tend to drive more cautiously and spend less time speeding. Other findings suggest that CBD is unlikely to interfere with daily activities or work performance. Additionally, CBD does not seem to cause feelings of being high or impair thinking skills. Overall, current evidence suggests CBD is unlikely to negatively impact driving abilities. ^{1 5 6 7 8}

Who Is on the Research Team?

Toni M Rudisill, PhD

Principal Investigator

West Virginia University

Are You a Good Fit for This Trial?

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9949874/

The Effects of Cannabidiol on the Driving Performance ... Those receiving CBD drove slower and spent less time speeding. Calculated effect sizes ranged from 0.03 to 0.36. Table 2. Primary and Secondary Performance ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06686914

The Effects of Cannabidiol on the Driving Performance ... The objectives/purpose of this study are to comprehensively investigate the effects of non-prescription CBD on driving performance, drowsiness, sedation, and ...

3. nature.com nature.com/articles/s41386-024-01847-w

Does acute cannabidiol (CBD) use impair performance? A ... These findings suggest that acute CBD alone is unlikely to significantly impair daily functioning or workplace performance.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9716488/

Effects of cannabidiol on simulated driving and cognitive ... Acute, oral CBD treatment does not appear to induce feelings of intoxication and is unlikely to impair cognitive function or driving performance (Registration: ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0924977X24000373

A randomised, placebo-controlled, double blind, crossover ... Effect of cannabidiol and Δ9-tetrahydrocannabinol on driving performance: a randomised clinical trial. JAMA, 324 (21) (2020), pp. 2177-2186, 10.1001/jama ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2773065422000517

The Effects of Cannabidiol on the Driving Performance ... A common side effect of cannabidiol is drowsiness, which could impact safe driving. This study's purpose was to determine the feasibility and whether ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.16746

Visual function and vehicle driving performance under the ... For the total circuit parameters, on average, crashes showed a slight decrease after CBD consumption and reaction time increased slightly in the ...

8. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2788264

Driving Performance and Cannabis Users' Perception of ... This randomized clinical trial studies the magnitude and time course of effects of cannabis on driving, effect of cannabis with different.