Evaluation of Smoked THC and CBD in Men and Women

NCT05037487 | Completed Phase 1 FDA Drug

• 1 other identifier: 21-001137
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of inhaled cannabis with varying amounts of 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

Cannabis; THC; CBD; Intoxication; Impairment

Outcome Measures

Primary Outcomes (4)

• Subjective drug effect ratings of impairment and abuse liability

  Peak subjective ratings of drug effects associated with abuse liability and impairment as measured using visual analogue scales (VAS; 1-100mm).

  6 hours

• Pharmacokinetics of THC, CBD and metabolites

  Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH after exposure (Tmax)

  6 hours

• Behavioral task performance as assessed by the DRUID App Score

  Trough composite scores on the DRUID App

  6 hour

• THC concentrations in oral fluid

  Peak levels of THC in oral fluid after exposure

  6 hour

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Smoked placebo cannabis

Drug: Placebo Cannabis

20 mg CBD

EXPERIMENTAL

Smoked cannabis with CBD

Drug: 20 mg CBD Cannabis

20 mg CBD + 20 mg THC

EXPERIMENTAL

Smoked cannabis with CBD and THC

Drug: 20 mg CBD + 20 mg THC Cannabis

20 mg THC

EXPERIMENTAL

Smoked cannabis with THC

Drug: 20 mg THC Cannabis

Interventions

Placebo Cannabis DRUG

Smoked placebo cannabis

Placebo

20 mg CBD Cannabis DRUG

Smoked cannabis with CBD

20 mg CBD

20 mg CBD + 20 mg THC Cannabis DRUG

Smoked cannabis with CBD and THC

20 mg CBD + 20 mg THC

20 mg THC Cannabis DRUG

Smoked cannabis with THC

20 mg THC

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; Marijuana Abuse

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Ziva Cooper, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

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: August 31, 2021
• First Posted: September 8, 2021
• Study Start: September 1, 2022
• Primary Completion: January 7, 2025
• Study Completion: June 8, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)