Recruiting

Observational Study

Sponsor:

Hartford Hospital

Code:

NCT03431987

Conditions

Marijuana Usage

Alcohol Drinking

Eligibility Criteria

Sex: All

Age: 21 - 40

Healthy Volunteers: Accepted

Interventions

One day with a dose of placebo cannabis paired with alcohol

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

Study Details

Brief 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

Study ID

NCT03431987

Start date

Jul 1, 2018

Status verified date

Aug, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Must have a current drivers license
  • Must have used marijuana and alcohol in combination before
  • Right handed

Exclusion Criteria:

  • Females who are pregnant or breastfeeding
  • Unable or unsafe to have an MRI
  • Any serious medical or neurological disorder
  • Any psychiatric disorder
  • No major head traumas

Study Design

Enrollment

13 participants

Anticipated

Interventions and Outcome Measures

Arms

Marijuana Users

Interventions

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%

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%

Primary outcome measure

  • Change in performance on simulated driving Gap Acceptance Task. [ Time Frame: Post Dose: 30 minutes, 2.5 hours, and 5 hours ]
  • Change in performance on simulated driving Road Tracking Task. [ Time Frame: Post Dose: 30 minutes, 2.5 hours, and 5 hours ]
  • Change in performance on simulated driving Car Following Task. [ Time Frame: Post Dose: 30 minutes, 2.5 hours, and 5 hours ]
  • Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices. [ Time Frame: Before Dose and Post Dose: 30 minutes and 2.5 hours ]
  • Change in concentration of THC/metabolites in blood samples. [ Time Frame: Before Dose and Post Dose: 30 minutes and 2.5 hours ]
  • Marijuana performance changes on the Critical Tracking Task. [ Time Frame: Post Dose: 2 hours, 4 hours and 6 hours ]
  • Intoxication induced performance changes on the Tower of London task. [ Time Frame: Post Dose: 2 hours, 4 hours and 6 hours ]
  • Intoxication induced performance changes on the Cogstate 1-back/2-back task. [ Time Frame: Post Dose: 2 hours, 4 hours and 6 hours ]
  • Intoxication induced performance changes on the Cogstate Detection Task. [ Time Frame: Post Dose: 2 hours, 4 hours and 6 hours ]
  • Intoxication induced performance changes on the Cogstate Set Shifting Task. [ Time Frame: Post Dose: 2 hours, 4 hours and 6 hours ]

Central Contacts and Locations

Locations

Olin Neuropsychiatry Research Center, Institute of Living, Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06108

Contacts

Principal Investigator:

Godfrey Pearlson, MD

More Information

Sponsor

Hartford Hospital

Last update posted

Aug 5, 2022

Last verified

Aug, 2022

Keywords

  • Marijuana
  • Alcohol
  • THC
  • fMRI
  • MRI
  • Driving Simulation
  • Cannabis
  • Intoxication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2022-08-05.