Evaluation of Oral THC and CBD in Men and Women (O-TACOFS)

Evaluation of Oral THC and CBD in Oral Fluid, Pharmacokinetics, and Subjective and Neurocognitive Effects in Men and Women

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Drug Abuse; Impairment; Intoxication by Drug
• Intervention / Treatment: Drug: Placebo; Drug: THC; Drug: CBD; Drug: THC + CBD

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 Type: Interventional
• Enrollment (Estimated): 22
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ziva Cooper, Phd; Phone Number: 310-206-9942; Email: zcooper@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles
      • Contact: Vince Acebo; Phone Number: 310-983-3417; Email: vacebo@mednet.ucla.edu
      • Contact: Ziva Cooper, Phd; Phone Number: 310-206-9942; Email: zcooper@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Oral placebo; sesame and MCT oil	Drug: Placebo; Oral placebo
Experimental: 20 mg THC; THC suspended in sesame oil	Drug: THC; Oral THC (20 mg)
Experimental: 20 mg CBD; CBD suspended in MCT oil	Drug: CBD; Oral CBD (20 mg)
Experimental: 20 mg THC + 20 mg CBD; THC and CBD in sesame and MCT oil	Drug: THC + CBD; Oral THC (20 mg) + CBD (20 mg)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Ziva Cooper, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2028

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: CBD; Impairment; THC; Intoxication
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Organic Chemicals; Hydrocarbons; Terpenes; Cannabinoids; Dronabinol
• Other Study ID Numbers: 21-007289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No