40 Participants Needed

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

Trial Summary

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.

What data supports the effectiveness of the drug combination of Active delta-9-THC and Active Ethanol on driving under the influence (DUI)?

Research indicates that using cannabis (which contains delta-9-THC) and alcohol together can affect driving performance and increase the risk of accidents. Studies have shown that both substances can impair cognitive and psychomotor abilities, which are crucial for safe driving.12345

Is it safe to combine ethanol and cannabinoids?

Research shows that combining ethanol (alcohol) and cannabinoids (like THC) can significantly impair driving performance, increasing the risk of accidents. Both substances alone can impair driving, but their combined use leads to more severe impairment, suggesting potential safety concerns.15678

How does the drug combination of ethanol and delta-9-THC affect driving impairment compared to other treatments?

The combination of ethanol and delta-9-THC is unique because it can significantly enhance driving impairment in an additive or even synergistic manner, compared to when each is used alone. This combination affects perceptual, cognitive, and motor functions more than either substance individually, making it particularly important to study in the context of driving under the influence.69101112

What is the purpose of this trial?

The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
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+

Findings from Research

A daily dose of 40 mg of rimonabant for 15 days effectively reduced the physiological effects of smoked cannabis, such as tachycardia, similar to a single higher dose of 90 mg on the first day of treatment.
While the 40 mg dose significantly decreased subjective effects of cannabis on day 8, it did not maintain this effect by day 15, indicating that repeated dosing may not consistently reduce the subjective experience of cannabis effects over time.
Single and multiple doses of rimonabant antagonize acute effects of smoked cannabis in male cannabis users.Huestis, MA., Boyd, SJ., Heishman, SJ., et al.[2019]
Vaporizing cannabis significantly increases blood levels of THC and its active metabolite 11-OH-THC, especially when combined with low-dose alcohol, which may lead to greater impairment in driving performance.
In a study of 32 adult cannabis smokers, those who consumed alcohol before vaporizing cannabis showed higher maximum blood concentrations of THC, suggesting that the combination of these substances could enhance impairment and should be carefully considered in driving-related regulations.
Controlled Cannabis Vaporizer Administration: Blood and Plasma Cannabinoids with and without Alcohol.Hartman, RL., Brown, TL., Milavetz, G., et al.[2019]
This study will assess the effects of both oral and vaporized cannabis on driving performance, cognitive abilities, and field sobriety in healthy adults, involving 64 participants across two double-blind, placebo-controlled trials.
By examining the impact of cannabis alone and in combination with alcohol, the research aims to enhance understanding of impairment levels, which could influence public policy and law enforcement standards regarding cannabis and alcohol use.
The effects of oral and vaporized cannabis alone, and in combination with alcohol, on driving performance using the STISIM driving simulator: A two-part, double-blind, double-dummy, placebo-controlled, randomized crossover clinical laboratory protocol.Zamarripa, CA., Novak, MD., Weerts, EM., et al.[2023]

References

Psychomotor performances relevant for driving under the combined effect of ethanol and synthetic cannabinoids: A systematic review. [2023]
Effect of Smoked Cannabis on Vigilance and Accident Risk Using Simulated Driving in Occasional and Chronic Users and the Pharmacokinetic-Pharmacodynamic Relationship. [2020]
Single and multiple doses of rimonabant antagonize acute effects of smoked cannabis in male cannabis users. [2019]
Controlled Cannabis Vaporizer Administration: Blood and Plasma Cannabinoids with and without Alcohol. [2019]
The effects of oral and vaporized cannabis alone, and in combination with alcohol, on driving performance using the STISIM driving simulator: A two-part, double-blind, double-dummy, placebo-controlled, randomized crossover clinical laboratory protocol. [2023]
Impairment due to cannabis and ethanol: clinical signs and additive effects. [2019]
Marijuana, alcohol and actual driving performance. [2022]
The effects of cannabis and alcohol on simulated arterial driving: Influences of driving experience and task demand. [2022]
Interaction between marihuana and ethanol: effects on psychomotor performance. [2019]
The interaction of ethanol and delta9-tetrahydrocannabinol in man: effects on perceptual, cognitive and motor functions. [2013]
Ethanol and delta9-tetrahydrocannabinol interactive effects on human perceptual, cognitive and motor functions. II. [2013]
The effect of (-) trans-delta9-tetrahydrocannabinol, alone and in combination with ethanol, on human performance. [2019]
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