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Examine the Feasibility of a Standardized Field Test for Marijuana and Alcohol Impairment: Laboratory Evaluations (Alc-NHTSA)

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ClinicalTrials.gov Identifier: NCT04856566
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Collaborators:
National Highway Traffic Safety Administration
Hartford Hospital
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Godfrey Pearlson, Yale University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Marijuana Impairment Alcohol Impairment Drug: Low Marijuana, Hash, THC, or Grass Drug: High Marijuana, Hash, THC, or Grass Drug: Placebo Drug: 0.05 BAC Alcohol Drug: 0.08 BAC Alcohol Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Examine the Feasibility of a Standardized Field Test for Marijuana and Alcohol Impairment: Laboratory Evaluations
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Ethanol

Arm Intervention/treatment
Experimental: Low Dose THC + 0.05 BAC Alc
Participants will receive low dose of THC along with alcohol leading to a BAC of 0.05.
Drug: Low Marijuana, Hash, THC, or Grass
Cannabis with low amount of THC
Other Names:
  • Marijuana
  • THC

Drug: 0.05 BAC Alcohol
Amount of alcohol when consumed leads to BAC of 0.05

Experimental: High Dose THC + 0.05 BAC Alc
Participants will receive high dose of THC along with alcohol leading to a BAC of 0.05.
Drug: High Marijuana, Hash, THC, or Grass
Cannabis with high amount of THC
Other Names:
  • Marijuana
  • THC

Drug: 0.05 BAC Alcohol
Amount of alcohol when consumed leads to BAC of 0.05

Experimental: Placebo Drug + 0.05 BAC Alc
Participants will receive placebo drug with no THC along with alcohol leading to a BAC of 0.05.
Drug: Placebo
Placebo drug with no THC

Drug: 0.05 BAC Alcohol
Amount of alcohol when consumed leads to BAC of 0.05

Experimental: Placebo Drug + 0.08 BAC Alc
Participants will receive placebo drug with no THC along with alcohol leading to a BAC of 0.08.
Drug: Placebo
Placebo drug with no THC

Drug: 0.08 BAC Alcohol
Amount of alcohol when consumed leads to BAC of 0.08




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.


Secondary Outcome Measures :
  1. Change in concentration of THC/metabolites in blood samples. [ Time Frame: Baseline and post drug administration at: 30 min; 2.5 hours ]
    Blood samples with be collected at 3 times throughout each day to assess for changes of THC and its metabolite levels.

  2. 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 ]
    Oral fluid samples with be collected at 3 times throughout each day to assess for changes of THC and its metabolite levels.

  3. Change in performance on simulated driving Road Tracking Task. [ Time Frame: Post drug administration at: 30 min; 2.5 hours, 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.

  4. Change in performance on simulated driving Car Following Task. [ Time Frame: Post drug administration at: 30 min; 2.5 hours, 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.

  5. Change in performance on simulated driving Gap Acceptance Task. [ Time Frame: Post drug administration at: 30 min; 2.5 hours, 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 oncoming traffic to overtake a stopped car.



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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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.

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): NCT04856566


Contacts
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Contact: Catherine Boyle, B.S 860-545-7548 Catherine.Boyle@hhchealth.org
Contact: Diana King, B.A 860-545-7563 Diana.King@hhchealth.org

Locations
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United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06106
Contact: Diana King, B.A    860-545-7563    Diana.King@hhchealth.org   
Contact: Catherine Boyle, B.S    860-545-7548    Catherine.Boyle@hhchealth.org   
Principal Investigator: Godfrey Pearlson, M.D         
Sponsors and Collaborators
Yale University
National Highway Traffic Safety Administration
Hartford Hospital
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Godfrey Pearlson, M.D Founding Director, Olin Neuropsychiatry Center; Yale University
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Responsible Party: Godfrey Pearlson, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT04856566    
Other Study ID Numbers: HHC-2020-0368
DTNH2216C00022 ( Other Identifier: Department of Transportation )
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 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 Godfrey Pearlson, Yale University:
marijuana
THC
cannabis
alcohol
driving
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs