Evaluation of Smoked THC and CBD in Men and Women

Phase 1

Recruiting

• Conditions: Impairment; Drug Abuse; Intoxication by Drug
• Interventions: Drug: 20 mg CBD + 20 mg THC Cannabis; Drug: 20 mg CBD Cannabis; Drug: Placebo Cannabis; Drug: 20 mg THC Cannabis

• Registration Number: NCT05037487
• Lead Sponsor: University of California, Los Angeles

Brief Summary

The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of inhaled cannabis with varying amounts of delta-9-tetrahydrocannabinol (THC), and cannabidiol (CBD) and to evaluate detection of recently smoked THC in oral fluid.

Detailed Description

This double-blind placebo controlled, within-subject study study will assess testing devices that can measure biochemical markers in oral fluid and neurocognitive-performance markers of recent cannabis use. Other pharmacodynamic effects of inhaled cannabis with CBD and THC will be determined and the pharmacokinetics of THC, CBD, and respective metabolites will be assessed in whole blood.

Study Timeline

• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-08-31
• Study First Posted: 2021-09-08
• Study Start: 2022-09-01
• Status Verified: 2024-07
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Male or non-pregnant and non-lactating females aged 21-55 years
• Report weekly-monthly use of cannabis (≤1 day per week) over the past month prior to screening,
• Not currently seeking treatment for their cannabis use
• Have a Body Mass Index from 18.5 - 34kg/m2.
• Able to perform all study procedures
• Must be using a contraceptive (hormonal or barrier methods)

Exclusion Criteria

• Meeting DSM-V criteria for moderate to severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine
• Any other Axis I disorder
• Report using other illicit drugs in the prior 4 weeks, other than cannabis.
• Current use of any medications that may affect study outcomes
• If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures.
• Pregnancy is exclusionary due to the possible effects of the study medication on fetal development.
• History of an allergic reaction or adverse reaction to cannabis is exclusionary.
• History of respiratory illness or current respiratory illness
• Currently enrolled in another research protocol
• Not using a contraceptive method (hormonal or barrier methods)
• The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
20 mg CBD + 20 mg THC	20 mg CBD + 20 mg THC Cannabis	Smoked cannabis with CBD and THC
20 mg CBD	20 mg CBD Cannabis	Smoked cannabis with CBD
Placebo	Placebo Cannabis	Smoked placebo cannabis
20 mg THC	20 mg THC Cannabis	Smoked cannabis with THC

Primary Outcome Measures

Name	Time	Method
Subjective drug effect ratings of impairment and abuse liability	6 hours	Peak subjective ratings of drug effects associated with abuse liability and impairment as measured using visual analogue scales (VAS; 1-100mm).
Behavioral task performance as assessed by the DRUID App Score	6 hour	Trough composite scores on the DRUID App
Pharmacokinetics of THC, CBD and metabolites	6 hours	Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH after exposure (Tmax)
THC concentrations in oral fluid	6 hour	Peak levels of THC in oral fluid after exposure

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States