High Confusion: Cannabis & Driving

Impairment, Cognitive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06236815
• Other study ID #: 2022-1124
• Secondary ID: A523000Protocol
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 2024
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: University of Wisconsin, Madison
• Contact: Heather Barkholtz, PhD
• Phone: 608-890-1967
• Email: hbarkholtz[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Confusion
• Impairment of Attention
• Impairment, Cognitive

Intervention

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) ?9-THC, (2) ?8-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-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) ?9-THC, (2) ?8-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.
• 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) ?9-THC, (2) ?8-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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 months
Primary	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.	9 months