Marijuana and Alcohol Effects on Driving Impairment
(Alc-NHTSA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how marijuana and alcohol together affect driving safety. Researchers will use a driving simulator to assess the impact of different doses of THC (the active component of marijuana) and alcohol. Participants will receive either a low or high dose of THC with a set amount of alcohol, or just alcohol without THC. Individuals who have used cannabis for at least two years, regularly drink and smoke, and hold a driver's license with recent highway experience may be suitable for this trial. As an Early Phase 1 trial, the study aims to understand the initial effects of combining THC and alcohol on driving, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have a severe substance use disorder (except for cannabis and tobacco) or certain medical conditions, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that mixing THC (the active ingredient in marijuana) with alcohol can impair driving ability. At low doses of THC with alcohol, studies find that marijuana users might drive more cautiously, such as by reducing speed. However, even this combination can still impair driving, especially at night.
With higher doses of THC and alcohol, the effects become more pronounced. Research indicates that reaction times significantly slow, causing drivers to take longer to respond to road conditions. This combination also leads drivers to maintain greater distances between cars and drive at lower speeds.
In both cases, while the impairments might seem minor, they can still increase the risk of accidents. These findings are crucial for understanding how these substances might affect safety, particularly when driving.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how different doses of THC, combined with alcohol, impact driving impairment. Unlike typical studies that look at alcohol or cannabis effects separately, this trial investigates the combined impact, which is more reflective of real-world scenarios. By including various combinations, such as low and high THC doses with alcohol, and comparing them to placebo groups, the trial aims to provide valuable insights into how these substances might impair driving abilities differently. This could lead to better-informed guidelines and safety measures for drivers who use these substances.
What evidence suggests that this trial's treatments could be effective for assessing driving impairment?
This trial will compare the effects of different combinations of THC and alcohol on driving impairment. Participants in one arm will receive a low dose of THC with alcohol, resulting in a BAC of 0.05, while another arm will involve a high dose of THC with the same BAC level. Additionally, some arms will administer a placebo drug with no THC, combined with alcohol at BAC levels of 0.05 and 0.08. Research has shown that using both low and high amounts of THC with alcohol can make driving unsafe. Studies find that driving is more affected when both THC and alcohol are used together than when either is used alone. Even small amounts of THC with alcohol can noticeably impair driving in tests. Higher amounts of THC with alcohol cause even more impairment, indicating a stronger effect on driving skills. These findings emphasize that THC, especially when mixed with alcohol, can greatly affect safe driving.16789
Who Is on the Research Team?
Godfrey Pearlson, M.D
Principal Investigator
Founding Director, Olin Neuropsychiatry Center; Yale University
Are You a Good Fit for This Trial?
This trial is for adults who regularly drink alcohol and smoke marijuana, with at least 2 years of cannabis use and driving experience. They must not be novice users, should have used cannabis at least five times in their life without withdrawal symptoms, and hold a valid driver's license.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive alcohol and marijuana doses followed by cognitive and simulated driving tests
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Laboratory Evaluations
- Standardized Field Test for Marijuana and Alcohol Impairment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Highway Traffic Safety Administration
Collaborator
National Highway Traffic Safety Administration (NHTSA)
Collaborator
Hartford Hospital
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator