Marijuana UsageNCT03431987
Neuroscience of Alcohol and Marijuana Impaired Driving
An observational study of Marijuana Usage and Alcohol Drinking, run by Hartford Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Usage, Alcohol Drinking
- What is being tested?
- One day with a dose of active THC cannabis paired with alcohol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All participants that meet the study criteria sampled from the general population
Who may be able to join
- Must have a current drivers license
- Must have used marijuana and alcohol in combination before
- Right handed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Olin Neuropsychiatry Research Center, Institute of Living, Hartford Hospital
Hartford, Connecticut, 06108
Lindsey Repoli, BS, 860-545-7233, lindsey.repoli@hhchealth.org
Catherine Boyle, BS, 860-545-7548, catherine.boyle@hhchealth.org
About this study
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.
Read the 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.
- Conditions
- Marijuana Usage, Alcohol Drinking
- Being tested
- One day with a dose of placebo cannabis paired with alcohol, One day with a dose of active THC cannabis paired with alcohol
- Keywords
- Marijuana, Alcohol, THC, fMRI, MRI, Driving Simulation, Cannabis, Intoxication
- Medical subject headings
- Alcohol Drinking, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One day with a dose of placebo cannabis paired with alcoholDrug
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 alcoholDrug
Vaporized marijuana with active THC paired with drinking alcohol to BrAC of 0.05%
| Study group | Role | What they receive |
|---|---|---|
| Marijuana Users | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance on simulated driving Gap Acceptance Task.
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.
Measured: Post Dose: 30 minutes, 2.5 hours, and 5 hours
Change in performance on simulated driving Road Tracking Task.
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.
Measured: Post Dose: 30 minutes, 2.5 hours, and 5 hours
Change in performance on simulated driving Car Following Task.
The Car Following Task measures tactical control of the vehicle. Tactical control of the vehicle is measured by following distance from a lead vehicle.
Measured: 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.
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.
Measured: Before Dose and Post Dose: 30 minutes and 2.5 hours
Change in concentration of THC/metabolites in blood samples.
Blood samples will be taken at 3 time points during the day to assess for changes in concentration of THC and its metabolites.
Measured: Before Dose and Post Dose: 30 minutes and 2.5 hours
Marijuana performance changes on the Critical Tracking Task.
The Critical Tracking Task assesses visuomotor tracking, it will be administered prior to dosing and at various time points after dosing
Measured: Post Dose: 2 hours, 4 hours and 6 hours
Intoxication induced performance changes on the Tower of London task.
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.
Measured: Post Dose: 2 hours, 4 hours and 6 hours
Intoxication induced performance changes on the Cogstate 1-back/2-back task.
The Cogstate 1-back/2-back task assesses working memory, it will be administered prior to dosing and at various time points after dosing.
Measured: Post Dose: 2 hours, 4 hours and 6 hours
Intoxication induced performance changes on the Cogstate Detection Task.
The Cogstate Detection Task assesses processing speed, it will be administered prior to dosing and at various time points after dosing.
Measured: Post Dose: 2 hours, 4 hours and 6 hours
Intoxication induced performance changes on the Cogstate Set Shifting Task.
The Cogstate Set Shifting Task assesses executive functioning, it will be administered prior to dosing and at various time points after dosing.
Measured: Post Dose: 2 hours, 4 hours and 6 hours
Secondary outcomes (3)
Change in magnetic resonance spectroscopy scanning.
Spectroscopy scanning will be completed to assess the change in chemical concentration of the brain.
Measured: Post Dose: 2.5 hours
Change in electroencephalography at rest.
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.
Measured: Post Dose: 10 minutes, 1.5 hours, 2.25 hours, 4.5 hours
Change in electroencephalography while completing the driving simulation.
EEG will be performed wearing a Cognionics 4 Channel Quick-20 EEG headset while the participant completes the driving simulation.
Measured: Post Dose: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Jul 2018
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana UsageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431987
- Sponsor's protocol ID
- HHC-2016-0183
- Status last verified
- Aug 2022
- First submitted
- 7 Feb 2018
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroscience of Alcohol and Marijuana Impaired Driving
- ClinicalTrials.gov ID
- NCT03431987
- Acronym / sponsor ID
- HHC-2016-0183
- Conditions
- Marijuana Usage, Alcohol Drinking
- Keywords
- Marijuana, Alcohol, THC, fMRI, MRI, Driving Simulation, Cannabis, Intoxication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Marijuana Users | – | 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 |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All participants that meet the study criteria sampled from the general population
Key inclusion criteria (3 listed)
- Must have a current drivers license
- Must have used marijuana and alcohol in combination before
- Right handed
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One day with a dose of placebo cannabis paired with alcoholVaporized placebo marijuana with little to no THC paired with drinking alcohol to BrAC of 0.05% | Drug | Marijuana Users |
| One day with a dose of active THC cannabis paired with alcoholVaporized marijuana with active THC paired with drinking alcohol to BrAC of 0.05% | Drug | Marijuana Users |
Primary outcome
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
3 secondary outcomes
Change in magnetic resonance spectroscopy scanning.
Time frame: 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
Change in electroencephalography while completing the driving simulation.
Time frame: Post Dose: 5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Marijuana Usage and Alcohol Drinking, run by Hartford Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lindsey Repoli, BS (860-545-7233, lindsey.repoli@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in performance on simulated driving Gap Acceptance Task. (time frame: Post Dose: 30 minutes, 2.5 hours, and 5 hours). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.