Examine the Feasibility of a Standardized Field Test for Marijuana and Alcohol Impairment: Laboratory Evaluations

NCT04856566 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: HHC-2020-0368DTNH2216C00022
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Marijuana Impairment; Alcohol Impairment

Keywords

marijuana; THC; cannabis; alcohol; driving

Outcome Measures

Primary Outcomes (16)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline and post drug administration at: 30 min; 2.5 hours

• Change in performance on simulated driving Road Tracking Task.

  Post drug administration at: 30 min; 2.5 hours, 5 hours

• Change in performance on simulated driving Car Following Task.

  Post drug administration at: 30 min; 2.5 hours, 5 hours

• Change in performance on simulated driving Gap Acceptance Task.

  Post drug administration at: 30 min; 2.5 hours, 5 hours

Study Arms (4)

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.

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.

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.

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.

Drug: Placebo; Drug: 0.08 BAC Alcohol

Interventions

Low Marijuana, Hash, THC, or Grass DRUG

Cannabis with low amount of THC

Also known as: Marijuana, THC

Low Dose THC + 0.05 BAC Alc

High Marijuana, Hash, THC, or Grass DRUG

Cannabis with high amount of THC

Also known as: Marijuana, THC

High Dose THC + 0.05 BAC Alc

Placebo DRUG

Placebo drug with no THC

Placebo Drug + 0.05 BAC Alc; Placebo Drug + 0.08 BAC Alc

0.05 BAC Alcohol DRUG

Amount of alcohol when consumed leads to BAC of 0.05

High Dose THC + 0.05 BAC Alc; Low Dose THC + 0.05 BAC Alc; Placebo Drug + 0.05 BAC Alc

0.08 BAC Alcohol DRUG

Amount of alcohol when consumed leads to BAC of 0.08

Placebo Drug + 0.08 BAC Alc

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Highway Traffic Safety Administration (NHTSA): collaborator
• Hartford Hospital: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximols; Dronabinol; Ethanol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Alcohols

Study Officials

• Godfrey Pearlson, M.D

  Founding Director, Olin Neuropsychiatry Center; Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 23, 2021
• Study Start: July 28, 2021
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: July 1, 2025

Record last verified: 2024-07

Locations

US (1)