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Cannabinoid

THC Testing for Cannabis Impairment (NHTSA-II Trial)

Phase 1
Waitlist Available
Led By Godfrey Pearlson, M.D
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18-55 years old
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.
Awards & highlights

NHTSA-II Trial Summary

This trial will aim to increase understanding of how smoked cannabis affects cognition and driving ability, as well as how long these effects last. It will also look at how prior experience with cannabis use affects these abilities.

Who is the study for?
This trial is for people aged 18-55 with a driver's license and at least 2 years of driving experience. Participants should be English speakers who have used cannabis recently and felt its effects. Excluded are those with adverse reactions to cannabis, low IQ, new users, drug or alcohol use on test day (except THC), pregnant or breastfeeding women, individuals unable to understand study instructions, former users abstaining from cannabis, anyone with significant head trauma or medical conditions affecting cognition.Check my eligibility
What is being tested?
The study tests the effects of smoked marijuana on tasks related to driving skills and cognitive functions over time after use. It compares medium THC levels against a placebo in participants with prior marijuana experience. The goal is to better understand how recent use impairs behavior relevant to driving.See study design
What are the potential side effects?
While not explicitly listed in the provided information, typical side effects of THC may include altered senses and sense of time, mood changes, impaired body movement, difficulty thinking and problem-solving as well as potential long-term mental health issues.

NHTSA-II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 55 years old.

NHTSA-II Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.
This trial's timeline: 3 weeks for screening, Varies for treatment, and post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Marijuana induced performance changes on Cogstate Groton Maze Learning task.
Marijuana induced performance changes on Inquisit Maze Learning task.
Marijuana induced performance changes on the Time Reproduction Task.
Secondary outcome measures
Change in concentration of THC/metabolites in blood samples.
Change in performance on simulated driving Road Tracking Task.

Side effects data

From 2019 Phase 4 trial • 46 Patients • NCT03008005
13%
Nausea and Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Oral Capsule
Dronabinol Cap 5 Milligrams (MG)
Dronabinol Cap 10 Milligrams (MG)

NHTSA-II Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo MarijuanaExperimental Treatment1 Intervention
Placebo Marijuana will be administered.
Group II: Medium THC MarijuanaExperimental Treatment1 Intervention
Medium THC marijuana will be administered.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,837 Previous Clinical Trials
2,728,381 Total Patients Enrolled
National Highway Traffic Safety Administration (NHTSA)FED
7 Previous Clinical Trials
909 Total Patients Enrolled
Hartford HospitalOTHER
132 Previous Clinical Trials
18,890 Total Patients Enrolled

Media Library

Medium THC (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05115513 — Phase 1
Cannabis Impairment Research Study Groups: Placebo Marijuana, Medium THC Marijuana
Cannabis Impairment Clinical Trial 2023: Medium THC Highlights & Side Effects. Trial Name: NCT05115513 — Phase 1
Medium THC (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05115513 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are youthful participants being accepted for the experiment?

"Participants must fall in the 18 to 55 year old demographic to be considered for this study. For those who are younger or older than that age bracket, there are various other trials available with different eligibility requirements."

Answered by AI

To what degree could consuming Medium THC be detrimental to a patient's health?

"The minimal evidence regarding Medium THC's safety and efficacy leads to a score of 1."

Answered by AI

What is the magnitude of people involved in this experiment?

"Affirmative. Clinicaltrials.gov data confirms that this medical experiment, which was originally posted on August 25th 2022, is currently recruiting participants. 32 individuals must be recruited from a single site for the trial's completion."

Answered by AI

Is this experiment pioneering a new approach?

"Presently, 32 cities across 5 countries are hosting 31 distinct clinical trials for a pharmaceutical called 'Medium THC'. Jazz Pharmaceuticals initiated the first study of its kind in 2015 and it was composed of 200 patients. Since then, 60 such experiments have been concluded."

Answered by AI

Are there any reports of previous research on the effects of Medium THC?

"Currently, 31 clinical trials involving Medium THC are actively running with 3 of them in their finale stage. Hartford Connecticut is the hub for many of these studies; however, there are 46 other locations that administer tests and collect data on this medication."

Answered by AI

Is enrollment still available for this experiment?

"Indeed, the information hosted on clinicaltrials.gov denotes that this investigation is presently recruiting participants. This venture was initially posted on August 25th 2022 and has since been amended; 32 people are sought from a single location."

Answered by AI

To what extent should certain individuals be targeted to enroll in this experiment?

"For acceptance into this trial, applicants should have a history of marijuana abuse and be between the ages of 18-55. This research project has 32 available slots in total."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Connecticut
Texas
How old are they?
18 - 65
What site did they apply to?
Olin Neuropsychiatry Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Olin Neuropsychiatry Research Center: < 48 hours
Average response time
  • < 2 Days
~12 spots leftby Mar 2025