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Neuroscience of Alcohol and Marijuana Impaired Driving

NCT03431987 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2022-08-05

No results posted yet for this study

Summary

Alcohol is one of the most widely used intoxicants. The effects of driving while intoxicated are well documented, leading to the laws and regulations behind drunk driving. Marijuana is also a commonly abused drug, whose use is increasing with widespread legalization/decriminalization in many US states and use of medical marijuana. Marijuana use is linked to cognitive impairment and is likely be the cause of intoxication-induced accidents. The effects of marijuana intoxication on driving impairments are less documented than those of alcohol. However, most marijuana users also consume alcohol when smoking cannabis, and preliminary data strongly suggest that driving impairment from both drugs used together is synergistic rather than just additive.

This study will aim to investigate the brain and behavior in the same individuals, using a similar design to the current Neuroscience of Marijuana Impaired Driving and the prior Alcohol and Driving Grant, that used similar techniques and measures to quantify drunk automobile driving. We hypothesize that alcohol and marijuana use combined will lead to greater impairment in a simulated driving task, as well as other driving-related cognitive impairments. In a randomized, counterbalanced, double-blind study, we will dose participants with alcohol to a legal level of 0.05% blood alcohol content, then we will administer a moderate inhaled dose of THC marijuana or placebo marijuana, using paced inhalation that employees a vaporizer. Participants will comprise 10 regular alcohol and marijuana consumers aged 21 to 40 years of age; all participants must report smoking marijuana and drinking alcohol together. Of the 10, 5 will be occasional marijuana smokers and 5 frequent marijuana smokers. Following this dosing, we will assess impairment through cognitive testing as well as a simulated driving test through fMRI and neuropsychological tests. Samples of breath, blood and oral fluid will also be collected at multiple time points throughout the study visits to be measured for alcohol and THC concentration and its metabolites. This allows clarification between the relationship of impairment, as well as subjective and objective intoxication, and levels of THC and its metabolites in the users system.

Conditions

  • Marijuana Usage
  • Alcohol Drinking

Interventions

DRUG

One day with a dose of placebo cannabis paired with alcohol

Vaporized placebo marijuana with little to no THC paired with drinking alcohol to BrAC of 0.05%

DRUG

One day with a dose of active THC cannabis paired with alcohol

Vaporized marijuana with active THC paired with drinking alcohol to BrAC of 0.05%

Sponsors & Collaborators

  • Hartford Hospital

    lead OTHER

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03431987 on ClinicalTrials.gov