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Not yet recruiting NCT05067387

Evaluation of Oral THC and CBD in Men and Women

Phase I Interventional Drug Abuse Intoxication by Drug Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo, THC, CBD, THC + CBD.
Who it may be relevant to
Registry conditions: Drug Abuse, Intoxication by Drug, Impairment. Basic parameters: 21 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Ratings of subjective drug effects [Time frame: 6 hours]
  • Concentration of THC, CBD and metabolites in whole blood [Time frame: 6 hours]
  • Behavioral task performance as assessed by the DRUID App Score [Time frame: 6 hours]
  • Concentration of THC in oral fluid [Time frame: 6 hours]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of California, Los Angeles — Los Angeles

Identifiers

NCT: NCT05067387 · 21-007289

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗