Evaluation of Oral THC and CBD in Men and Women

Phase 1

Not yet recruiting

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

• Registration Number: NCT05067387
• Lead Sponsor: University of California, Los Angeles

Brief Summary

The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of oral 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 THC or CBD use. Other pharmacodynamic effects of oral THC or CBD will be determined and the pharmacokinetics of THC, CBD, and respective metabolites will be assessed in whole blood.

Study Timeline

• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-10-05
• Status Verified: 2024-12
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Study Start: 2025-07
• Primary Completion: 2027-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: NOT_YET_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
Placebo	Placebo	Oral placebo; sesame and MCT oil
20 mg THC	THC	THC suspended in sesame oil
20 mg CBD	CBD	CBD suspended in MCT oil
20 mg THC + 20 mg CBD	THC + CBD	THC and CBD in sesame and MCT oil

Primary Outcome Measures

Name	Time	Method
Ratings of subjective drug effects	6 hours	Average and peak subjective ratings of drug effects associated with abuse liability as measured using visual analogue scales (VAS; 1-100mm).
Concentration of THC, CBD and metabolites in whole blood	6 hours	Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH as measured in ng/ml
Behavioral task performance as assessed by the DRUID App Score	6 hours	Composite score on the DRUID App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance
Concentration of THC in oral fluid	6 hours	Liquid chromatography-tandem mass spectrometry

Trial Locations

Locations (1)

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