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Neuroscience of Alcohol and Marijuana Impaired Driving

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ClinicalTrials.gov Identifier: NCT03431987
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : July 26, 2021
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Marijuana Usage Alcohol Drinking Drug: One day with a dose of placebo cannabis paired with alcohol Drug: One day with a dose of active THC cannabis paired with alcohol

Detailed Description:

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.

Data are being gathered currently in regards to the risk of marijuana-impaired driving from our NIDA-funded Neuroscience of Marijuana Impaired Driving study. Previously we had a grant award from NIAAA that investigated alcohol-impaired driving using a similar design. The current proposed study combines elements of both the NIDA and NIAAA studies, to assess the cognitive and brain impairment due to the simultaneous combination of beverage alcohol and smoked marijuana.

Our own prior NIAAA-funded grant, the Brain and Alcohol Research with College Students (BARCS) study, along with epidemiological investigations reveal that most marijuana smokers also consume alcohol when intoxicated. These drugs interact pharmacodynamically and change each other's levels in the user's blood and saliva reference Marilyn study. They both have separate, deleterious effects on driving. These effects are not additive but rather multiplicative. A person using both substances will show more deleterious effects on driving performance than the same individual using just one of these substances. 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 13 participants
Observational Model: Other
Time Perspective: Other
Official Title: Neuroscience of Alcohol and Marijuana Impaired Driving
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Ethanol

Groups and Cohorts
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Group/Cohort Intervention/treatment
Marijuana Users 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%


Outcome Measures
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Primary Outcome Measures :
  1. Change in performance on simulated driving Gap Acceptance Task. [ Time Frame: Post Dose: 30 minutes, 2.5 hours, and 5 hours ]
    The Gap Acceptance Task measures strategic control of the vehicle. Strategic control of the vehicle is measured by size of headway gaps that the participant chooses in pulling out into a stream of traffic.

  2. Change in performance on simulated driving Road Tracking Task. [ Time Frame: Post Dose: 30 minutes, 2.5 hours, and 5 hours ]
    The Road Tracking Task measures operational control of the vehicle. Operational control is measured by standard deviation of lane position from the center point of the lane.

  3. Change in performance on simulated driving Car Following Task. [ Time Frame: Post Dose: 30 minutes, 2.5 hours, and 5 hours ]
    The Car Following Task measures tactical control of the vehicle. Tactical control of the vehicle is measured by following distance from a lead vehicle.

  4. 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 ]
    Saliva samples will be taken at 3 time points during the day using the Quantisal Oral Fluid Collection devices to assess for changes in concentration of THC and its metabolites.

  5. Change in concentration of THC/metabolites in blood samples. [ Time Frame: Before Dose and Post Dose: 30 minutes and 2.5 hours ]
    Blood samples will be taken at 3 time points during the day to assess for changes in concentration of THC and its metabolites.

  6. Marijuana performance changes on the Critical Tracking Task. [ Time Frame: Post Dose: 2 hours, 4 hours and 6 hours ]
    The Critical Tracking Task assesses visuomotor tracking, it will be administered prior to dosing and at various time points after dosing

  7. Intoxication induced performance changes on the Tower of London task. [ Time Frame: Post Dose: 2 hours, 4 hours and 6 hours ]
    The Tower of London is a task that assesses executive functioning, it will be administered prior to dosing and at various time points after dosing.

  8. Intoxication induced performance changes on the Cogstate 1-back/2-back task. [ Time Frame: Post Dose: 2 hours, 4 hours and 6 hours ]
    The Cogstate 1-back/2-back task assesses working memory, it will be administered prior to dosing and at various time points after dosing.

  9. Intoxication induced performance changes on the Cogstate Detection Task. [ Time Frame: Post Dose: 2 hours, 4 hours and 6 hours ]
    The Cogstate Detection Task assesses processing speed, it will be administered prior to dosing and at various time points after dosing.

  10. Intoxication induced performance changes on the Cogstate Set Shifting Task. [ Time Frame: Post Dose: 2 hours, 4 hours and 6 hours ]
    The Cogstate Set Shifting Task assesses executive functioning, it will be administered prior to dosing and at various time points after dosing.


Secondary Outcome Measures :
  1. Change in magnetic resonance spectroscopy scanning. [ Time Frame: Post Dose: 2.5 hours ]
    Spectroscopy scanning will be completed to assess the change in chemical concentration of the brain.

  2. Change in electroencephalography at rest. [ Time Frame: Post Dose: 10 minutes, 1.5 hours, 2.25 hours, 4.5 hours ]
    EEG will be performed at several time points during the day wearing a Cognionics 4 Channel Quick-20 EEG headset while the participants sits and relaxes.

  3. Change in electroencephalography while completing the driving simulation. [ Time Frame: Post Dose: 5 hours ]
    EEG will be performed wearing a Cognionics 4 Channel Quick-20 EEG headset while the participant completes the driving simulation.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All participants that meet the study criteria sampled from the general population
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431987


Contacts
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Contact: Lindsey Repoli, BS 860-545-7233 lindsey.repoli@hhchealth.org
Contact: Suyash Adhikari, BS 860-545-7106 Suyash.Adhikari@hhchealth.org

Locations
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United States, Connecticut
Olin Neuropsychiatry Research Center, Institute of Living, Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06108
Contact: Lindsey Repoli, BS    860-545-7233    lindsey.repoli@hhchealth.org   
Contact: Catherine Boyle, BS    860-545-7548    catherine.boyle@hhchealth.org   
Principal Investigator: Godfrey Pearlson, MD         
Principal Investigator: Lindsey Repoli, BS         
Sponsors and Collaborators
Hartford Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT03431987    
Other Study ID Numbers: HHC-2016-0183
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hartford Hospital:
Marijuana
Alcohol
THC
fMRI
 MRI
Driving Simulation
Cannabis
Intoxication
Additional relevant MeSH terms:
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Marijuana Abuse
Alcohol Drinking
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drinking Behavior
 Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs