Evaluation of Oral THC and CBD in Men and Women

Drug Abuse Clinical Trial

— O-TACOFS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05067387
• Other study ID #: 21-007289
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2024
• Est. completion date: March 2026

Study information

• Verified date: November 2023
• Source: University of California, Los Angeles
• Contact: Ziva Cooper, PhD
• Phone: 310-206-9942
• Email: zcooper[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Abuse
• Impairment
• Intoxication by Drug
• Substance-Related Disorders

Intervention

Drug:
• Placebo
Oral placebo
• THC
Oral THC (20 mg)
• CBD
Oral CBD (20 mg)
• THC + CBD
Oral THC (20 mg) + CBD (20 mg)

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Concentration of THC in oral fluid	Liquid chromatography-tandem mass spectrometry	6 hours