Marijuana ImpairmentEarly Phase 1Alc-NHTSANCT04856566
Examine the Feasibility of a Standardized Field Test for Marijuana and Alcohol Impairment: Laboratory Evaluations
A Early Phase 1 study testing Low Marijuana, Hash, THC, or Grass, High Marijuana, Hash, THC, or Grass and 0.05 BAC Alcohol in people with Marijuana Impairment and Alcohol Impairment, run by Yale University at 1 site in United States.
Trial summary
Alcohol and Cannabis (CNB) are two of the most widely used intoxicants. The effects of driving while intoxicated on alcohol are well documented, resulting in numerous drunken driving laws and regulations. As CNB begins to be decriminalized, medical CNB use allowed in multiple U.S. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Impairment, Alcohol Impairment
- What is being tested?
- Low Marijuana, Hash, THC, or Grass, High Marijuana, Hash, THC, or Grass and 0.05 BAC Alcohol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2021to 23 Aug 2023
- Phase
- Early Phase 1
- 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
Who may be able to join
- Must have a driver's license; recent 2 years highway driving experience
- Cannabis use for at least the past 2 years and report of getting high when smoking cannabis to avoid recruiting novice/inexperienced users.
- Reports regularly drinking and smoking (does not need to be at the same time)
- Use cannabis at least 5 times within life up to daily use, with occasional day of abstinence with no symptoms of craving or withdrawal.
Who cannot join
- Pregnancy, breastfeeding, and ineffective birth control methods.
- Current severe substance use disorder (except cannabis and tobacco substance use disorders)
- history of adverse effects with cannabis use
- serious medical, neuro-ophthalmological, or neurological illness (i.e. cancer, seizure disorders, encephalopathy)
- current diagnosis of any DSM-5 psychiatric disorder
- prior diagnosis of any DSM-5 psychiatric disorder
Show all 10Show fewer
- report of any psychotic disorder in a first-degree relative
- history of head trauma with loss of consciousness > 30 minutes or concussion lasting 30 days.
- any medical/neurological condition that could compromise neurocognitive performance (i.e. epilepsy, multiple sclerosis, fetal alcohol syndrome)
- recovering alcoholics or anyone currently abstaining from alcohol.
Trial locations and contacts
1 site in 1 country.
About this study
Alcohol and Cannabis (CNB) are two of the most widely used intoxicants. The effects of driving while intoxicated on alcohol are well documented, resulting in numerous drunken driving laws and regulations. As CNB begins to be decriminalized, medical CNB use allowed in multiple U.S. states, and perception of harmfulness falls, CNB use is predicted to rise and it will become increasingly common to publicly encounter persons who recently used the drug. An area of potentially high concern is if ever-greater numbers of CNB users and its legalization will increase the risk of driving while intoxicated from recent CNB use, thereby increasing the risks to public safety. This study aims to examine the combined effects of smoking marijuana and drinking alcohol on simulated driving.
Read the detailed description
Alcohol is one of the most widely used substances. The effects of driving while intoxicated are well documented, leading to laws and regulations behind drunk driving. Marijuana is also a commonly abused drug. Marijuana use is not specific to social class, is linked to cognitive impairment and may be the cause of intoxication-induced accidents. The effects of marijuana intoxication on driving impairments are less documented. Data is being gathered in regards to this risk from our Neuroscience of Marijuana Impaired Driving study. The principle investigator's previous research includes the Brain and Alcohol Research with College Students (BARCS) study along with additional epidemiological studies reveal that most marijuana smokers also consume alcohol when they are intoxicated. These drugs interact pharmacodynamically and change each other's levels in the user's blood. They both have deleterious effects on driving. These effects are not additive but rather multiplicative. Someone using both substances will show more deleterious effects than someone 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 NHTSA: Examine the Feasibility of a Standardized Field Test for Marijuana Impairment study. This structure coupled with past alcohol driving studies (Marijauna and Alcohol Impaired Driving) uses similar techniques of other measures of drunk 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. This study will aim to study feasible roadside sobriety tests for marijuana impairment.
The study will consist of 5 days (screening visit and 4 dose visit days). In a randomized, counterbalanced, double-blind study, investigators will dose participants with alcohol to a legal amount of 0.05% blood alcohol content on 3 study days and dose to 0.08% blood alcohol content on 1 study day. Then investigators will administer high THC marijuana, low THC marijuana or placebo marijuana using paced inhalation through a vaporizer. Participants will include 12 regular alcohol consumers aged 21 to 40 years of age; all participants must report smoking and drinking together. Following this dosing, investigators will assess impairment through cognitive testing as well as a simulated driving test and neuropsychological tests. Samples of blood will also be collected at multiple time points throughout the study visits to be measured for 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 it's metabolites in the users system.
- Conditions
- Marijuana Impairment, Alcohol Impairment
- Being tested
- Low Marijuana, Hash, THC, or Grass, High Marijuana, Hash, THC, or Grass, Placebo, 0.05 BAC Alcohol, 0.08 BAC Alcohol
- Keywords
- marijuana, THC, cannabis, alcohol, driving
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Marijuana, Hash, THC, or GrassDrug
Also called Marijuana, THC
Cannabis with low amount of THC
High Marijuana, Hash, THC, or GrassDrug
Also called Marijuana, THC
Cannabis with high amount of THC
PlaceboDrug
Placebo drug with no THC
0.05 BAC AlcoholDrug
Amount of alcohol when consumed leads to BAC of 0.05
0.08 BAC AlcoholDrug
Amount of alcohol when consumed leads to BAC of 0.08
| Study group | Role | What they receive |
|---|---|---|
| Low Dose THC + 0.05 BAC Alc | Experimental | Participants will receive low dose of THC along with alcohol leading to a BAC of 0.05. Receives: Drug: Low Marijuana, Hash, THC, or Grass; Drug: 0.05 BAC Alcohol |
| High Dose THC + 0.05 BAC Alc | Experimental | Participants will receive high dose of THC along with alcohol leading to a BAC of 0.05. Receives: Drug: High Marijuana, Hash, THC, or Grass; Drug: 0.05 BAC Alcohol |
| Placebo Drug + 0.05 BAC Alc | Experimental | Participants will receive placebo drug with no THC along with alcohol leading to a BAC of 0.05. Receives: Drug: Placebo; Drug: 0.05 BAC Alcohol |
| Placebo Drug + 0.08 BAC Alc | Experimental | Participants will receive placebo drug with no THC along with alcohol leading to a BAC of 0.08. Receives: Drug: Placebo; Drug: 0.08 BAC Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marijuana and alcohol induced performance changes on 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: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Cogstate Social/Emotional Cognition Task.
The Cogstate Social/Emotional Cognition task assesses emotional processing, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on Cogstate Card Learning.
The Cogstate Card Learning task assesses visual memory, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on Groton Maze Learning task.
The Cogstate Groton Maze Learning task assesses spatial learning and memory, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on Alertmeter.
The Alertmeter task assess visual judgment and alertness, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Time Estimation task.
The Time Estimation Task assesses timing, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Go-No-Go task.
The Go-No-Go task assesses inhibitory processing, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Ramaeker's Critical Tracking Test.
The Raemaker's Critical Tracking Test assesses hand eye coordination and visuomotor tracking, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the ANAM Pursuit Tracking Task.
The ANAM Pursuit Tracking Task assesses hand eye coordination, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Finger to Nose Task.
The Finger to Nose Task assesses general motor coordination, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the One Leg Stand Task.
The One Leg Stand Task assesses general motor coordination, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Line Walking/Months Backwards Task.
The Line Walking/Months Backwards Task assesses general motor coordination plus distraction, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Time Reproduction Task.
The Time Reproduction Task assesses general motor coordination plus timing, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Ipod Balance Task.
Participants will have an elastic wrap around their hips with an Ipod attached via durable velco. They will be asked to stand with both feet flat on the ground, looking ahead at a fixed point on the wall for 30 seconds, as well as 30 seconds with eyes closed. The amount of body sway will be measured using the accelerometer in an Ipod.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the Ipod Punching Task.
Participants will have an elastic wrap around their forearm with an Ipod attached via durable velrco. They will be asking to punch their arm forward while seated in a chair to measure their peak velocity of punching through the accelerometer in the Ipod.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Marijuana and alcohol induced performance changes on the DRUID tasks.
DRUID is an application that has been designed to measure cognitive and behavior impairment following ingestion of drugs such as alcohol or marijuana. DRUID includes four Tasks to measure performance. The tasks are based on research on driving impairment and take about 5 minutes to complete. These tasks include a Reaction Time/Decision Making/DAT in which the subject has to press in two different locations on the Ipod screen dependent on which target shape appeared. The second task is a Reaction Time/Time Estimation/DAT task in which the subjects has to internally count up to 60 seconds while also touching the screen each time a target shape appears on the screen. The third task is a Motor Tracking/DAT tasks in which the subject must keep their finger on a moving circle on the screen. The last task is a balance task in which the subject is told to stand on one foot with the Ipod in an opposite hand keeping it as still as possible.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Secondary outcomes (5)
Change in concentration of THC/metabolites in blood samples.
Blood samples with be collected at 3 times throughout each day to assess for changes of THC and its metabolite levels.
Measured: Baseline and post drug administration at: 30 min; 2.5 hours
Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices.
Oral fluid samples with be collected at 3 times throughout each day to assess for changes of THC and its metabolite levels.
Measured: Baseline and post drug administration at: 30 min; 2.5 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 drug administration at: 30 min; 2.5 hours, 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 drug administration at: 30 min; 2.5 hours, 5 hours
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 oncoming traffic to overtake a stopped car.
Measured: Post drug administration at: 30 min; 2.5 hours, 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start28 Jul 2021
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana ImpairmentStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Highway Traffic Safety Administration (NHTSA), Hartford Hospital, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Godfrey Pearlson, Yale University
- Investigators
- Godfrey Pearlson, M.D, Principal investigator, Founding Director, Olin Neuropsychiatry Center; Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856566
- Sponsor's protocol ID
- HHC-2020-0368
- Other IDs
- DTNH2216C00022
- Acronym
- Alc-NHTSA
- Status last verified
- Jul 2024
- First submitted
- 19 Apr 2021
- Last updated
- 1 Jul 2025
- 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examine the Feasibility of a Standardized Field Test for Marijuana and Alcohol Impairment: Laboratory Evaluations
- ClinicalTrials.gov ID
- NCT04856566
- Acronym / sponsor ID
- Alc-NHTSA / HHC-2020-0368
- Conditions
- Marijuana Impairment, Alcohol Impairment
- Keywords
- marijuana, THC, cannabis, alcohol, driving
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Highway Traffic Safety Administration (NHTSA), Hartford Hospital, National Institute on Drug Abuse (NIDA)
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 23 Apr 2021 (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 and Cannabis (CNB) are two of the most widely used intoxicants. The effects of driving while intoxicated on alcohol are well documented, resulting in numerous drunken driving laws and regulations. As CNB begins to be decriminalized, medical CNB use allowed in multiple U.S. states, and perception of harmfulness falls, CNB use is predicted to rise and it will become increasingly common to publicly encounter persons who recently used the drug. An area of potentially high concern is if ever-greater numbers of CNB users and its legalization will increase the risk of driving while intoxicated from recent CNB use, thereby increasing the risks to public safety. This study aims to examine the combined effects of smoking marijuana and drinking alcohol on simulated driving.
Detailed description
Alcohol is one of the most widely used substances. The effects of driving while intoxicated are well documented, leading to laws and regulations behind drunk driving. Marijuana is also a commonly abused drug. Marijuana use is not specific to social class, is linked to cognitive impairment and may be the cause of intoxication-induced accidents. The effects of marijuana intoxication on driving impairments are less documented. Data is being gathered in regards to this risk from our Neuroscience of Marijuana Impaired Driving study. The principle investigator's previous research includes the Brain and Alcohol Research with College Students (BARCS) study along with additional epidemiological studies reveal that most marijuana smokers also consume alcohol when they are intoxicated. These drugs interact pharmacodynamically and change each other's levels in the user's blood. They both have deleterious effects on driving. These effects are not additive but rather multiplicative. Someone using both substances will show more deleterious effects than someone 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 NHTSA: Examine the Feasibility of a Standardized Field Test for Marijuana Impairment study. This structure coupled with past alcohol driving studies (Marijauna and Alcohol Impaired Driving) uses similar techniques of other measures of drunk 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. This study will aim to study feasible roadside sobriety tests for marijuana impairment.
The study will consist of 5 days (screening visit and 4 dose visit days). In a randomized, counterbalanced, double-blind study, investigators will dose participants with alcohol to a legal amount of 0.05% blood alcohol content on 3 study days and dose to 0.08% blood alcohol content on 1 study day. Then investigators will administer high THC marijuana, low THC marijuana or placebo marijuana using paced inhalation through a vaporizer. Participants will include 12 regular alcohol consumers aged 21 to 40 years of age; all participants must report smoking and drinking together. Following this dosing, investigators will assess impairment through cognitive testing as well as a simulated driving test and neuropsychological tests. Samples of blood will also be collected at multiple time points throughout the study visits to be measured for 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 it's metabolites in the users system.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Dose THC + 0.05 BAC Alc | Experimental | Drug: Low Marijuana, Hash, THC, or Grass, Drug: 0.05 BAC AlcoholParticipants will receive low dose of THC along with alcohol leading to a BAC of 0.05. |
| High Dose THC + 0.05 BAC Alc | Experimental | Drug: High Marijuana, Hash, THC, or Grass, Drug: 0.05 BAC AlcoholParticipants will receive high dose of THC along with alcohol leading to a BAC of 0.05. |
| Placebo Drug + 0.05 BAC Alc | Experimental | Drug: Placebo, Drug: 0.05 BAC AlcoholParticipants will receive placebo drug with no THC along with alcohol leading to a BAC of 0.05. |
| Placebo Drug + 0.08 BAC Alc | Experimental | Drug: Placebo, Drug: 0.08 BAC AlcoholParticipants will receive placebo drug with no THC along with alcohol leading to a BAC of 0.08. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Must have a driver's license; recent 2 years highway driving experience
- Cannabis use for at least the past 2 years and report of getting high when smoking cannabis to avoid recruiting novice/inexperienced users.
- Reports regularly drinking and smoking (does not need to be at the same time)
- Use cannabis at least 5 times within life up to daily use, with occasional day of abstinence with no symptoms of craving or withdrawal.
Key exclusion criteria (10 listed)
- Pregnancy, breastfeeding, and ineffective birth control methods.
- Current severe substance use disorder (except cannabis and tobacco substance use disorders)
- history of adverse effects with cannabis use
- serious medical, neuro-ophthalmological, or neurological illness (i.e. cancer, seizure disorders, encephalopathy)
- current diagnosis of any DSM-5 psychiatric disorder
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 |
|---|---|---|
| Low Marijuana, Hash, THC, or GrassAlso: Marijuana, THCCannabis with low amount of THC | Drug | Low Dose THC + 0.05 BAC Alc |
| High Marijuana, Hash, THC, or GrassAlso: Marijuana, THCCannabis with high amount of THC | Drug | High Dose THC + 0.05 BAC Alc |
| PlaceboPlacebo drug with no THC | Drug | Placebo Drug + 0.05 BAC Alc, Placebo Drug + 0.08 BAC Alc |
| 0.05 BAC AlcoholAmount of alcohol when consumed leads to BAC of 0.05 | Drug | High Dose THC + 0.05 BAC Alc, Low Dose THC + 0.05 BAC Alc, Placebo Drug + 0.05 BAC Alc |
| 0.08 BAC AlcoholAmount of alcohol when consumed leads to BAC of 0.08 | Drug | Placebo Drug + 0.08 BAC Alc |
Primary outcome
Marijuana and alcohol induced performance changes on Cogstate 1-back/2-back task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 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.
Marijuana and alcohol induced performance changes on the Cogstate Social/Emotional Cognition Task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
The Cogstate Social/Emotional Cognition task assesses emotional processing, it will be administered prior to dosing and at various time points after dosing.
Marijuana and alcohol induced performance changes on Cogstate Card Learning.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
The Cogstate Card Learning task assesses visual memory, it will be administered prior to dosing and at various time points after dosing.
Marijuana and alcohol induced performance changes on Groton Maze Learning task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
The Cogstate Groton Maze Learning task assesses spatial learning and memory, it will be administered prior to dosing and at various time points after dosing.
Marijuana and alcohol induced performance changes on Alertmeter.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
The Alertmeter task assess visual judgment and alertness, it will be administered prior to dosing and at various time points after dosing.
Marijuana and alcohol induced performance changes on the Time Estimation task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
The Time Estimation Task assesses timing, it will be administered prior to dosing and at various time points after dosing.
Marijuana and alcohol induced performance changes on the Go-No-Go task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
The Go-No-Go task assesses inhibitory processing, it will be administered prior to dosing and at various time points after dosing.
Marijuana and alcohol induced performance changes on the Ramaeker's Critical Tracking Test.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
The Raemaker's Critical Tracking Test assesses hand eye coordination and visuomotor tracking, it will be administered prior to dosing and at various time points after dosing.
Marijuana and alcohol induced performance changes on the ANAM Pursuit Tracking Task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
The ANAM Pursuit Tracking Task assesses hand eye coordination, it will be administered prior to dosing and at various time points after dosing.
Marijuana and alcohol induced performance changes on the Finger to Nose Task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
The Finger to Nose Task assesses general motor coordination, it will be administered prior to dosing and at various time points after dosing.
Marijuana and alcohol induced performance changes on the One Leg Stand Task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
The One Leg Stand Task assesses general motor coordination, it will be administered prior to dosing and at various time points after dosing.
Marijuana and alcohol induced performance changes on the Line Walking/Months Backwards Task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
The Line Walking/Months Backwards Task assesses general motor coordination plus distraction, it will be administered prior to dosing and at various time points after dosing.
Marijuana and alcohol induced performance changes on the Time Reproduction Task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
The Time Reproduction Task assesses general motor coordination plus timing, it will be administered prior to dosing and at various time points after dosing.
Marijuana and alcohol induced performance changes on the Ipod Balance Task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Participants will have an elastic wrap around their hips with an Ipod attached via durable velco. They will be asked to stand with both feet flat on the ground, looking ahead at a fixed point on the wall for 30 seconds, as well as 30 seconds with eyes closed. The amount of body sway will be measured using the accelerometer in an Ipod.
Marijuana and alcohol induced performance changes on the Ipod Punching Task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Participants will have an elastic wrap around their forearm with an Ipod attached via durable velrco. They will be asking to punch their arm forward while seated in a chair to measure their peak velocity of punching through the accelerometer in the Ipod.
Marijuana and alcohol induced performance changes on the DRUID tasks.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
DRUID is an application that has been designed to measure cognitive and behavior impairment following ingestion of drugs such as alcohol or marijuana. DRUID includes four Tasks to measure performance. The tasks are based on research on driving impairment and take about 5 minutes to complete. These tasks include a Reaction Time/Decision Making/DAT in which the subject has to press in two different locations on the Ipod screen dependent on which target shape appeared. The second task is a Reaction Time/Time Estimation/DAT task in which the subjects has to internally count up to 60 seconds while also touching the screen each time a target shape appears on the screen. The third task is a Motor Tracking/DAT tasks in which the subject must keep their finger on a moving circle on the screen. The last task is a balance task in which the subject is told to stand on one foot with the Ipod in an opposite hand keeping it as still as possible.
5 secondary outcomes
Change in concentration of THC/metabolites in blood samples.
Time frame: Baseline and post drug administration at: 30 min; 2.5 hours
Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices.
Time frame: Baseline and post drug administration at: 30 min; 2.5 hours
Change in performance on simulated driving Road Tracking Task.
Time frame: Post drug administration at: 30 min; 2.5 hours, 5 hours
Change in performance on simulated driving Car Following Task.
Time frame: Post drug administration at: 30 min; 2.5 hours, 5 hours
Change in performance on simulated driving Gap Acceptance Task.
Time frame: Post drug administration at: 30 min; 2.5 hours, 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
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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.
Godfrey Pearlson, M.D principal investigator
Founding Director, Olin Neuropsychiatry Center; Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Low Marijuana, Hash, THC, or Grass, High Marijuana, Hash, THC, or Grass and 0.05 BAC Alcohol in people with Marijuana Impairment and Alcohol Impairment, run by Yale University 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 1 Jul 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marijuana and alcohol induced performance changes on Cogstate 1-back/2-back task. (time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours). The study lists 16 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 1 Jul 2025.