Alcohol + Cannabinoid Effects on DUI

(THC-ETOH-III Trial)

Overseen By Christina Luddy, BS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Yale University

Disqualifiers: Cannabis naïve, Alcohol naïve, Pregnancy, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

Trial Summary

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

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

What data supports the effectiveness of the drug Active Dronabinol, Active Ethanol, Placebo, Control, Dummy Treatment in the clinical trial Alcohol + Cannabinoid Effects on DUI?

Research shows that combining alcohol and cannabis can significantly impair driving skills, suggesting that the drug's effectiveness in this trial may relate to understanding and measuring impairment levels when these substances are used together. ^{1 2 3 4 5}

Is it safe to combine alcohol and cannabinoids like dronabinol?

Research shows that combining alcohol and cannabinoids can impair driving performance and psychomotor skills, but there is no specific mention of severe safety concerns in healthy adults. However, caution is advised as the combination can enhance impairment effects. ^{1 2 6 7 8}

How does the drug used in the Alcohol + Cannabinoid Effects on DUI trial differ from other treatments for driving under the influence?

This trial is unique because it examines the combined effects of vaporized cannabis and alcohol on driving impairment, which is not typically addressed in standard DUI treatments. It focuses on the interaction between these substances and their impact on subjective experiences and psychomotor performance, providing insights into how they might jointly affect driving abilities. ^{2 3 5 9 10}

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 alcohol and cannabis at least once. They must be able to understand and agree to the study's terms. Pregnant individuals, those with hearing issues, no prior use of cannabis or alcohol (naïve), or a sesame oil allergy cannot participate.

Inclusion Criteria

I am between 21 and 55 years old.

Exposed to cannabis at least once

Exposed to alcohol at least once

Exclusion Criteria

Cannabis naïve

Alcohol naïve

Positive pregnancy screen

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive ethanol clamped at BAC 0.04% and oral Dronabinol (10 mg capsule) to study effects on simulated driving and cognition

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Active Dronabinol
• Active Ethanol
• Placebo

Trial Overview The study aims to assess how active Dronabinol (a synthetic THC), ethanol (alcohol), and placebo affect simulated driving performance and related thinking skills. Participants will receive these substances in a controlled environment.

Participant Groups

Group I: Placebo THC and Active Ethanol Experimental Treatment 2 Interventions

Group II: Active THC and Placebo Ethanol Experimental Treatment 2 Interventions

Group III: Active THC and Active Ethanol Experimental Treatment 2 Interventions

Group IV: Placebo THC and Placebo Ethanol Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

This study is the first randomized controlled trial to evaluate the effectiveness of dronabinol, a form of Δ9-THC, in reducing opioid consumption in adults with traumatic injuries, involving 122 participants over a 48-hour treatment period.

The trial aims to determine if adding dronabinol to standard pain management can lower the amount of opioids needed, potentially offering a safer alternative for pain relief in acute injury situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Dronabinol for Acute Pain Management in Adults with Traumatic Injury: Study Protocol of A Randomized Controlled Trial. Swartwood, C., Salottolo, K., Madayag, R., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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]

2. England pubmed.ncbi.nlm.nih.gov

Interaction between marihuana and ethanol: effects on psychomotor performance. [2019]

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

Cannabis and temporal disintegration in experienced and naive subjects. [2019]

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

Effect of Smoked Cannabis on Vigilance and Accident Risk Using Simulated Driving in Occasional and Chronic Users and the Pharmacokinetic-Pharmacodynamic Relationship. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Controlled vaporized cannabis, with and without alcohol: subjective effects and oral fluid-blood cannabinoid relationships. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Psychomotor performances relevant for driving under the combined effect of ethanol and synthetic cannabinoids: A systematic review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The effects of cannabis and alcohol on simulated arterial driving: Influences of driving experience and task demand. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of Dronabinol for Acute Pain Management in Adults with Traumatic Injury: Study Protocol of A Randomized Controlled Trial. [2020]

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

Single and multiple doses of rimonabant antagonize acute effects of smoked cannabis in male cannabis users. [2019]

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

Comparative effects of alcohol and marijuana on mood, memory, and performance. [2019]