NCT06236815

High Confusion: Cannabis & Driving

High Confusion: Evaluating Effects of Popular Cannabis Isolates on Driving Performance

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This study is being done to assess the feasibility of administrating Δ9-THC and Δ8-THC isolates and simultaneously adopting several data harmonization measures to generate uniquely translatable data. This project aims to (1) evaluate the feasibility and acceptability of administering ∆9-THC and Δ8-THC isolates using standardized cannabis dosing units to quantify ∆9-THC and Δ8-THC pharmacokinetics; and (2) evaluate the feasibility and acceptability of adopting standardized impairment detection methods and driving performance definitions and measures on quantifying ∆9-THC and Δ8-THC driving impairment compared to a placebo.

Conditions

• Impairment, Cognitive
• Impairment of Attention
• Impairment, Psychomotor

Interventions

Type	Name	Description
DRUG	Delta-9-THC	Healthy volunteers will attend three test sessions, at least 14 days apart, in which cognition and driving performance will be assessed following vaporization of (1) Δ9-THC, (2) Δ8-THC, or (3) a placebo. The order of these conditions will be counterbalanced across participants. Serial blood samples will be drawn during each dosing visit and compared with concurrent dried blood spots from a finger stick.
DRUG	Delta-8-THC	Healthy volunteers will attend three test sessions, at least 14 days apart, in which cognition and driving performance will be assessed following vaporization of (1) Δ9-THC, (2) Δ8-THC, or (3) a placebo. The order of these conditions will be counterbalanced across participants. Serial blood samples will be drawn during each dosing visit and compared with concurrent dried blood spots from a finger stick.
DRUG	Placebo	Healthy volunteers will attend three test sessions, at least 14 days apart, in which cognition and driving performance will be assessed following vaporization of (1) Δ9-THC, (2) Δ8-THC, or (3) a placebo. The order of these conditions will be counterbalanced across participants. Serial blood samples will be drawn during each dosing visit and compared with concurrent dried blood spots from a finger stick.

Timeline

• Start date: 2025-01-25
• Primary completion: 2025-09-16
• Completion: 2025-09-16
• First posted: 2024-02-01
• Last updated: 2025-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study