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

Sponsor

University of California, Los Angeles (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05067387

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

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
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.

Study Design

Study Type:

Interventional

Anticipated 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.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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

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:

Yes

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:

Substance-Related Disorders

Dronabinol

Study Results

No Results Posted as of Jun 10, 2022