- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03431987
Neuroscience of Alcohol and Marijuana Impaired Driving
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Lindsey Repoli, BS
- Phone Number: 860-545-7233
- Email: lindsey.repoli@hhchealth.org
Study Contact Backup
- Name: Suyash Adhikari, BS
- Phone Number: 860-545-7106
- Email: Suyash.Adhikari@hhchealth.org
Study Locations
-
-
Connecticut
-
Hartford, Connecticut, United States, 06108
- Recruiting
- Olin Neuropsychiatry Research Center, Institute of Living, Hartford Hospital
-
Contact:
- Lindsey Repoli, BS
- Phone Number: 860-545-7233
- Email: lindsey.repoli@hhchealth.org
-
Contact:
- Catherine Boyle, BS
- Phone Number: 860-545-7548
- Email: catherine.boyle@hhchealth.org
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Principal Investigator:
- Lindsey Repoli, BS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Marijuana Users
|
Vaporized placebo marijuana with little to no THC paired with drinking alcohol to BrAC of 0.05%
Vaporized marijuana with active THC paired with drinking alcohol to BrAC of 0.05%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
|
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.
|
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
|
The Car Following Task measures tactical control of the vehicle.
Tactical control of the vehicle is measured by following distance from a lead vehicle.
|
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
|
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.
|
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
|
Blood samples will be taken at 3 time points during the day to assess for changes in concentration of THC and its metabolites.
|
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
|
The Critical Tracking Task assesses visuomotor tracking, it will be administered prior to dosing and at various time points after dosing
|
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
|
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.
|
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
|
The Cogstate 1-back/2-back task assesses working memory, it will be administered prior to dosing and at various time points after dosing.
|
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
|
The Cogstate Detection Task assesses processing speed, it will be administered prior to dosing and at various time points after dosing.
|
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
|
The Cogstate Set Shifting Task assesses executive functioning, it will be administered prior to dosing and at various time points after dosing.
|
Post Dose: 2 hours, 4 hours and 6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Post Dose: 2.5 hours
|
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.
|
Post Dose: 10 minutes, 1.5 hours, 2.25 hours, 4.5 hours
|
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.
|
Post Dose: 5 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HHC-2016-0183
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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