High Confusion: Cannabis & Driving

Early Phase 1CompletedNCT06236815

University of Wisconsin, Madison5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Impairment, Cognitive Impairment of Attention Impairment, Psychomotor

Interventions

Delta-9-THCDRUG

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.

Delta-8-THCDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Quantify analyte concentrations

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.

Time frame: 9 months

Quantify impairing effects of cannabinoids

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.