High Confusion: Cannabis & Driving

Early Phase 1

Recruiting

• Conditions: Impairment, Psychomotor; Impairment, Cognitive; Impairment of Attention
• Interventions: Drug: Delta-8-THC; Drug: Placebo; Drug: Delta-9-THC

• Registration Number: NCT06236815
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-24
• Study First Posted: 2024-02-01
• Study Start: 2025-01-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• At least 18 years of age, no older than 49 years of age
• Recent cannabis use (within past two years)
• Good mental health as determined by self-reported responses to the Psychopathology Screener
• Absence of any major medical, cardiovascular, endocrine, and neurological condition as determined by self-reported responses to the Medical History Screener
• In possession of a valid drivers' license with at least two years of driving experience
• English-speaking (able to provide consent and complete questionnaires)
• Written Informed Consent

Exclusion Criteria

• Any serious prior adverse response to cannabis
• History of or current substance use disorder as determined by self-reported responses to the Internalizing, Externalizing, and Substance Use Disorder Screener
• Pregnancy or lactation (pregnancy test, if needed)
• Use of medications that may impact driving ability (e.g., mood stabilizers, sedatives)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
delta-8-THC	Delta-8-THC	-
Placebo	Placebo	-
delta-9-THC	Delta-9-THC	-

Primary Outcome Measures

Name	Time	Method
Quantify impairing effects of cannabinoids	9 months	Quantify the impairing effects of delta-9-THC and delta-8-THC by measuring the standard deviation of lateral position within the driving simulation and by completing a drug recognition expert field sobriety test for signs of impairment.
Quantify analyte concentrations	9 months	Quantify delta-9-THC, delta-8-THC, and their primary metabolites in whole blood, plasma, oral fluid, and dried blood spots at several time points before and after acute study drug administration.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States