Neuroscience of Alcohol and Marijuana Impaired Driving

Neuroscience of Alcohol and Marijuana Impaired Driving



Sponsors

Lead Sponsor



Source

Hartford Hospital

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No


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.

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.

Overall Status

Recruiting

Start Date

2018-05-01

Completion Date

2019-05-01

Primary Completion Date

2019-05-01

Phase

N/A

Study Type

Observational

Primary Outcome

Measure

Time Frame

Change in performance on simulated driving Gap Acceptance Task.
Post Dose: 30 minutes, 2.5 hours, and 5 hours
Change in performance on simulated driving Road Tracking Task.
Post Dose: 30 minutes, 2.5 hours, and 5 hours
Change in performance on simulated driving Car Following Task.
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.
Before Dose and Post Dose: 30 minutes and 2.5 hours
Change in concentration of THC/metabolites in blood samples.
Before Dose and Post Dose: 30 minutes and 2.5 hours
Marijuana performance changes on the Critical Tracking Task.
Post Dose: 2 hours, 4 hours and 6 hours
Intoxication induced performance changes on the Tower of London task.
Post Dose: 2 hours, 4 hours and 6 hours
Intoxication induced performance changes on the Cogstate 1-back/2-back task.
Post Dose: 2 hours, 4 hours and 6 hours
Intoxication induced performance changes on the Cogstate Detection Task.
Post Dose: 2 hours, 4 hours and 6 hours
Intoxication induced performance changes on the Cogstate Set Shifting Task.
Post Dose: 2 hours, 4 hours and 6 hours

Secondary Outcome

Measure

Time Frame

Change in magnetic resonance spectroscopy scanning.
Post Dose: 2.5 hours
Change in electroencephalography at rest.
Post Dose: 10 minutes, 1.5 hours, 2.25 hours, 4.5 hours
Change in electroencephalography while completing the driving simulation.
Post Dose: 5 hours

Number Of Groups

1

Enrollment

13

Conditions


Intervention

Intervention Type

Drug

Intervention Name


Description

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

Arm Group Label

Marijuana Users


Intervention Type

Drug

Intervention Name


Description

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

Arm Group Label

Marijuana Users



Eligibility

Study Pop

All participants that meet the study criteria sampled from the general population

Sampling Method

Probability Sample

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

Gender

All

Minimum Age

21 Years

Maximum Age

40 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Contact

Last Name

Lindsey Repoli, BS

Phone

860-545-7233

Email



Location

Facility

Status

Contact

Investigator

Olin Neuropsychiatry Research Center, Institute of Living, Hartford Hospital
Hartford Connecticut 06108 United States
Recruiting
Last Name: Lindsey Repoli, BS
Phone: 860-545-7233
Email: [email protected]
Last Name: Godfrey Pearlson, MD
Role: Principal Investigator

Last Name: Lindsey Repoli, BS
Role: Principal Investigator


Location Countries

Country

United States


Verification Date

2018-05-01

Lastchanged Date

2018-02-07

Firstreceived Date

2018-02-07

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Condition Browse


Intervention Browse

Mesh Term

Ethanol


Arm Group

Arm Group Label

Marijuana Users


Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Catherine Boyle, BS

Phone

860-545-7548

Email



Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Other

Time Perspective

Other


Study First Submitted

February 7, 2018

Study First Submitted Qc

February 7, 2018

Study First Posted

February 13, 2018

Last Update Submitted

May 9, 2018

Last Update Submitted Qc

May 9, 2018

Last Update Posted

May 15, 2018


ClinicalTrials.gov processed this data on May 15, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



© 2018 ICH GCP