Ethanol + Cannabinoid Effects on DUI

(THC-ETOH Trial)

CL
LT
CO
Overseen ByChloe Ouchida, BA
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Yale University

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how alcohol and cannabinoids, such as THC from cannabis, affect driving and thinking skills. Participants will receive either active delta-9-THC, alcohol, both, or a placebo to assess the impact on simulated driving. This trial suits individuals who have previously tried both cannabis and alcohol. For those curious about how these substances might alter driving abilities, this presents an interesting opportunity. As a Phase 1 trial, the research focuses on understanding how these substances work in people, offering a unique chance to contribute to this knowledge.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

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

Research shows that both delta-9-THC (a compound in cannabis) and alcohol significantly affect the body. Studies indicate that delta-9-THC can slow reaction time, impair coordination, and alter perception, which are crucial for activities like driving. These effects can sometimes lead to reduced mental functioning and poorer driving skills.

For alcohol, research consistently shows it greatly impairs driving abilities. Drinking alcohol raises the risk of car accidents, especially as blood alcohol concentration (BAC) levels increase. Using both delta-9-THC and alcohol together increases these risks more than using either one alone, as their combined effects cause greater impairment.

This trial is in its first phase, focusing on the safety of these treatments. While existing information covers each substance separately, this study will examine their combined effects. Treatments reaching this stage are generally considered somewhat safe, but this study aims to gather more detailed information.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about exploring the effects of combining active delta-9-THC and ethanol on driving under the influence (DUI) because it targets interactions between cannabinoids and alcohol, which are commonly used substances. Unlike traditional DUI studies that often focus on a single substance, this trial examines how these two substances together might impair driving skills differently than when used alone. This approach could lead to a better understanding of how combined substance use impacts driving, potentially influencing future safety guidelines and interventions.

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

This trial will examine the effects of cannabis and alcohol on driving ability. Research has shown that both substances can impair driving skills. For cannabis, studies indicate that driving skills typically return to normal about 5 to 7 hours after use, although individuals often feel they must try harder to drive safely while under its influence. Alcohol is well-known for greatly increasing the risk of car accidents. Combining alcohol and cannabis often makes driving even more dangerous than using either substance alone. These findings underscore the risks of driving after using these substances. Participants in this trial will be assigned to different groups to assess the effects of active THC, active ethanol, or their combination on driving performance.45678

Are You a Good Fit for This Trial?

This trial is for men and women aged 21 to 55 who have used cannabis and alcohol at least once. They must be able to understand and agree to the study's terms. Pregnant individuals, those who've never consumed alcohol or cannabis, or people with hearing problems cannot participate.

Inclusion Criteria

I am between 21 and 55 years old.
Exposed to alcohol at least once
Exposed to cannabis at least once
See 1 more

Exclusion Criteria

I have hearing problems.
Cannabis naive
Positive pregnancy screen
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive ethanol and/or THC to study their effects on simulated driving and cognition

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Active delta-9-THC
  • Active Ethanol
Trial Overview The study aims to assess how ethanol (alcohol) and cannabinoids (like THC from cannabis) affect simulated driving performance and cognitive functions related to driving. Participants will receive either a placebo, active THC, or active ethanol during the trial.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Placebo THC and Active EthanolExperimental Treatment2 Interventions
Group II: Active THC and Placebo EthanolExperimental Treatment2 Interventions
Group III: Active THC and Active EthanolExperimental Treatment2 Interventions
Group IV: Placebo THC and Placebo EthanolPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

Published Research Related to This Trial

The study found that combining ethanol and marihuana significantly worsened psychomotor performance, particularly skills needed for driving, indicating an additive or synergistic effect on impairment.
Interestingly, taking ethanol before smoking marihuana did not significantly affect subjective feelings of intoxication, heart rate, or THC levels in the blood, suggesting that the combination primarily impacts performance rather than subjective experiences.
Interaction between marihuana and ethanol: effects on psychomotor performance.Perez-Reyes, M., Hicks, RE., Bumberry, J., et al.[2019]
High doses of cannabis significantly impaired driving performance more than lower doses, while alcohol had minimal effects and did not enhance impairment when combined with cannabis.
Both substances increased speed and variability in driving, but high-dose cannabis led to decreased mean speed and longer reaction times, highlighting the need for further research on their individual effects on driving safety.
The effects of cannabis and alcohol on simulated arterial driving: Influences of driving experience and task demand.Lenné, MG., Dietze, PM., Triggs, TJ., et al.[2022]
The study of 589 drivers showed that while blood THC concentration is related to specific physical signs like conjunctival injection and pupil dilation, it does not correlate with most clinical tests for impairment.
When THC and ethanol are present together, the risk of being judged impaired significantly increases, indicating that their combined effects on driving ability are greater than either substance alone.
Impairment due to cannabis and ethanol: clinical signs and additive effects.Bramness, JG., Khiabani, HZ., Mørland, J.[2019]

Citations

Driving Under the Influence of AlcoholOver 30% of motor vehicle traffic fatalities were caused by alcohol-impaired driving, resulting in 10,874 lives lost and $44 billion costs incurred in 2017 ...
Impact of alcohol driving-while-impaired license ...This study aimed to 1) examine the association between type of recent alcohol-DWI suspension and having a secondary alcohol-related license outcome and/or ...
Driving under the influence of alcohol: frequency, reasons ...Results showed around 60% of respondents believe that driving under the influence of alcohol is maximum risk behavior. Nevertheless, 90.2% of ...
Driving Under the Influence of Alcohol, Marijuana, and ...During 2002–2014, the prevalence of driving under the influence of alcohol alone significantly declined by 59% among persons aged 16–20 years ( ...
Alcohol and drugsAt a BAC of 0.08% compared with a zero BAC, the likelihood of involvement in a fatal crash is 10 times as high among 16-20 year-old drivers, 7 times as high ...
Drunk Driving | Statistics and ResourcesIn 2023, there were 2,117 people killed in alcohol-related crashes where a driver had a BAC of .01 to .07 g/dL. BAC is measured with a breathalyzer, a device ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37186642/
Alcohol and driving-How bad is the combination? A meta ...The effect of BAC on crash and injury risk and culpability is stronger at higher BAC levels and for more serious outcomes.
Impaired Driving FactsIn 2020, 11,654 people were killed in motor vehicle crashes involving alcohol-impaired drivers, accounting for 30% of all traffic-related deaths ...
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