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 weeks3 visits

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.

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.