High Confusion: Cannabis & Driving

University of Wisconsin (UW)

Status and phase: Completed; Early Phase 1

Conditions: Impairment, Cognitive; Impairment, Psychomotor; Impairment of Attention

Treatments: Drug: Delta-8-THC; Drug: Delta-9-THC; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06236815

Protocol Version 2/5/2025 (Other Identifier)

A523000 (Other Identifier)

2022-1124

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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5 participants in 3 patient groups, including a placebo group

delta-9-THC

Experimental group

Treatment:

Drug: Delta-9-THC

delta-8-THC

Experimental group

Treatment:

Drug: Delta-8-THC

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo