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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05067387
Recruitment Status : Not yet recruiting
First Posted : October 5, 2021
Last Update Posted : June 10, 2022
Sponsor:
Information provided by (Responsible Party):
Ziva D. Cooper, PhD, 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.

Condition or disease Intervention/treatment Phase
Drug Abuse Intoxication by Drug Impairment Drug: Placebo Drug: THC Drug: CBD Drug: THC + CBD 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
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.
Masking: 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
Estimated Study Start Date : August 2022
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2024

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)




Primary Outcome Measures :
  1. Ratings of subjective drug effects [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 hours ]
    Liquid chromatography-tandem mass spectrometry



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05067387


Contacts
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Contact: Ziva Cooper, PhD 310-206-9942 zcooper@mednet.ucla.edu

Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Contact: Ziva Cooper, PhD    310-206-9942    zcooper@mednet.ucla.edu   
Contact: Vince Acebo    310-983-3417    vacebo@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Ziva Cooper University of California, Los Angeles
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Responsible Party: Ziva D. Cooper, PhD, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT05067387    
Other Study ID Numbers: 21-007289
First Posted: October 5, 2021    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ziva D. Cooper, PhD, University of California, Los Angeles:
THC
CBD
Intoxication
Impairment
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists