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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
Must not have
Uncontrolled, persistent high blood pressure
History of head trauma with loss of consciousness > 30 minutes or concussion lasting 30 days
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.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My high blood pressure is not under control.
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I have had a head injury that made me unconscious for more than 30 minutes or caused a concussion for 30 days.
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I do not have conditions like epilepsy that affect my brain function.
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I have a history of serious illness, including cancer or neurological issues.
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I have had bad reactions to cannabis in the past.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Change in concentration of THC/metabolites in blood samples.
Change in performance on simulated driving Road Tracking Task.

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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,426 Total Patients Enrolled
1 Trials studying Cannabis Intoxication
9 Patients Enrolled for Cannabis Intoxication
National Highway Traffic Safety Administration (NHTSA)FED
7 Previous Clinical Trials
909 Total Patients Enrolled
Hartford HospitalOTHER
139 Previous Clinical Trials
19,661 Total Patients Enrolled
1 Trials studying Cannabis Intoxication
9 Patients Enrolled for Cannabis Intoxication
National Institute on Drug Abuse (NIDA)NIH
2,607 Previous Clinical Trials
3,329,903 Total Patients Enrolled
2 Trials studying Cannabis Intoxication
180 Patients Enrolled for Cannabis Intoxication
Godfrey Pearlson, M.DPrincipal InvestigatorYale University
3 Previous Clinical Trials
42 Total Patients Enrolled

Media Library

Medium THC (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05115513 — Phase 1
Cannabis Intoxication Research Study Groups: Placebo Marijuana, Medium THC Marijuana
Cannabis Intoxication 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
~1 spots leftby Feb 2025
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