Evaluation of Oral THC and CBD in Men and Women

NCT05067387 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 21-007289
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Abuse; Intoxication by Drug; Impairment

Keywords

THC; CBD; Intoxication; Impairment

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Oral placebo; sesame and MCT oil

Drug: Placebo

20 mg THC

EXPERIMENTAL

THC suspended in sesame oil

Drug: THC

20 mg CBD

EXPERIMENTAL

CBD suspended in MCT oil

Drug: CBD

20 mg THC + 20 mg CBD

EXPERIMENTAL

THC and CBD in sesame and MCT oil

Drug: THC + CBD

Interventions

Placebo DRUG

Oral placebo

Placebo

THC DRUG

Oral THC (20 mg)

20 mg THC

CBD DRUG

Oral CBD (20 mg)

20 mg CBD

THC + CBD DRUG

Oral THC (20 mg) + CBD (20 mg)

20 mg THC + 20 mg CBD

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• History of respiratory illness or current respiratory illness
• Currently enrolled in another research protocol
• Not using a contraceptive method (hormonal or barrier methods)

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Ziva Cooper

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziva Cooper, PhD

CONTACT

310-206-9942; zcooper@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 5, 2021
• Study Start: April 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)