Summary

Eligibility
for people ages 21-55 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Ziva Cooper, PhD (ucla)

Description

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.

Official Title

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

Details

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 cannabis use. Other pharmacodynamic effects of inhaled cannabis with CBD and THC will be determined and the pharmacokinetics of THC, CBD, and respective metabolites will be assessed in whole blood.

Keywords

Drug Abuse, Intoxication by Drug, Impairment, Cannabis, THC, CBD, Intoxication, Substance-Related Disorders, Dronabinol, 20 mg CBD Cannabis, 20 mg CBD + 20 mg THC Cannabis, 20 mg THC Cannabis

Eligibility

You can join if…

Open to people ages 21-55

  • 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 CAN'T join 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.
  • 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.

Location

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at University of California Health

  • Ziva Cooper, PhD (ucla)
    Associate Professor-in-Residence, Psychiatry and Biobehavioral Sciences, Medicine. Authored (or co-authored) 69 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT05037487
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 22 study participants
Last Updated