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

University of California, Los Angeles (Other)
Overall Status
Not yet recruiting
CT.gov ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Anticipated Enrollment :
22 participants
Intervention Model:
Crossover Assignment
Intervention Model Description:
This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Evaluation of Oral THC and CBD in Oral Fluid, Pharmacokinetics, and Subjective and Neurocognitive Effects in Men and Women
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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

  3. 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

  4. Concentration of THC in oral fluid [6 hours]

    Liquid chromatography-tandem mass spectrometry

Eligibility Criteria


Ages Eligible for Study:
21 Years to 55 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 University of California, Los Angeles Los Angeles California United States 90095

Sponsors and Collaborators

  • University of California, Los Angeles


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

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Ziva D. Cooper, PhD, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • 21-007289
First Posted:
Oct 5, 2021
Last Update Posted:
Jun 10, 2022
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Ziva D. Cooper, PhD, Associate Professor, University of California, Los Angeles
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2022