Standardized Field Test for Marijuana Impairment II

NCT05115513 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: HHC-2021-0333DTNH2216C000222000032628
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This research responds to NHTSA's request with a proposal to increase our understanding of smoked cannabis' (CNB's) acute effects on driving-relevant cognition and simulated driving performance, the persistence of these deficits over the hours after use, and the influence of prior experience with CNB on these effects. This extension study will aim to further investigate marijuana impaired behavior, using a similar design to our previous NHTSA Examine the Feasibility of a Standardized Field Test for Marijuana Impairment and the prior NIDA Neuroscience of Marijuana-Impaired Driving award, that used similar techniques and measures to quantify marijuana impaired automobile driving. We will be utilizing tasks and assessments that were shown to be strong indicators for cognitive and driving impairment in our NHTSA study.

Conditions

Marijuana Impairment

Keywords

Marijuana; THC; Cannabis; Driving; Impairment; Intoxication

Outcome Measures

Primary Outcomes (3)

• Marijuana induced performance changes on Cogstate 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.

  Post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.

• Marijuana induced performance changes on Inquisit Maze Learning task.

  The Inquisit Maze Learning task assesses spatial learning and memory, it will be administered prior to dosing and at various time points after dosing.

  Post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.

• Marijuana 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.

  Post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.

Secondary Outcomes (2)

• Change in concentration of THC/metabolites in blood samples.

  Post placebo at 5 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.

• Change in performance on simulated driving Road Tracking Task.

  Post placebo at 10 minutes and post active dose administration at 210 minutes.

Study Arms (2)

Placebo Marijuana

EXPERIMENTAL

Placebo Marijuana will be administered.

Drug: Placebo THC

Medium THC Marijuana

EXPERIMENTAL

Medium THC marijuana will be administered.

Drug: Medium THC

Interventions

Medium THC DRUG

Marijuana flower with medium THC

Medium THC Marijuana

Placebo THC DRUG

Marijuana flower with no THC

Placebo Marijuana

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• yrs/ old
• Current driver's license and history of repeated highway vehicle driving experience (at least 2 years)
• Recent, recurrent CNB use and felt high when used
• Able to read, speak, and understand English
• Able and willing to provide written informed consent, and willing to commit to the study protocol

You may not qualify if:

• Current marijuana tolerance, desire to cut down, or cravings to use during periods of abstinence
• New CNB users who have not used at least once during their lifetime.
• Positive screen for drug and alcohol (except THC) on test day will result in rescheduling the appointment
• Former CNB users who are abstaining
• Pregnancy, breastfeeding, and ineffective birth control methods.
• History of adverse psychological or medical effects following cannabis use
• serious medical, neuro-ophthalmological, or neurological illness (i.e. cancer, seizure disorders, encephalopathy)
• History of head trauma with loss of consciousness \> 30 minutes or concussion lasting 30 days.
• IQ \<80 on the Wechsler Abbreviated Scale of Intelligence
• Inability to comprehend written instructions using the WRAT 4 reading achievement test
• Any medical/neurological condition that could compromise neurocognitive performance (i.e. epilepsy, multiple sclerosis, fetal alcohol syndrome)
• Uncontrolled, persistent high blood pressure
• Anyone deemed unsafe to study personnel for any reason

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)

Olin Neuropsychiatry Research Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

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

Study Officials

• Godfrey Pearlson, M.D

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Neuroscience, Founding Director Olin Neuropsychiatry Research Center

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 10, 2021
• Study Start: August 25, 2022
• Primary Completion: August 21, 2023
• Study Completion: August 21, 2023
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)