High Confusion: Cannabis & Driving

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

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.

Sponsors & Collaborators

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• Heather Barkholtz, PhD · University of Wisconsin, Madison

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-25

Primary Completion

2025-09-16

Completion

2025-09-16

FDA Drug

Yes

Countries

• United States

Study Locations