Summary

Eligibility
for people ages 18-65 (full criteria)
Healthy Volunteers
healthy people welcome
Dates
study started
completion around
Principal Investigator
by Ziva Cooper, PhD (ucla)
Headshot of Ziva Cooper
Ziva Cooper

Description

Summary

This study will assess the age-dependent effects of smoked and oral THC on abuse liability, intoxication, analgesia and impairment as a function of age.

Official Title

Sex- and AGE-dependent Effects of Smoked and Oral Delta-9-THC

Details

The overall objective of this placebo-controlled, outpatient study is to compare the dose-dependent effects of smoked and oral THC on analgesia and endpoints directly related to adverse consequences of use including abuse liability, intoxication, and impairment as a function of age and sex.

Keywords

Pain, Abuse, Drug, Intoxication; Cannabinoids, Cannabis, Delta-9-THC, Age, Sex, Substance-Related Disorders, Dronabinol

Eligibility

You can join if…

Open to people ages 18-65

  • Male or non-pregnant female aged 18-65 years according to the below criteria: EMERGING

    ADULTS: 18-25 years of age (+/- one year) MIDDLE-AGED ADULTS: 35-45 years of age (+/- one year) LATE MIDDLE-AGED ADULTS: 55-65 years of age (+/- one year)

  • Report weekly-monthly use of cannabis (with primary mode of use via inhalation) over the past 6 months prior to screening
  • Not currently seeking treatment for their cannabis use
  • No reported clinically significant adverse effects with cannabis use
  • Have a Body Mass Index from 18.5 - 34kg/m2
  • Able to perform all study procedures
  • FEMALES: Currently practicing an effective form of birth control if pre-menopausal

You CAN'T join if...

  • Meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria for any substance use disorder other than nicotine and mild cannabis use disorder
  • Report using other illicit drugs in the prior 4 weeks
  • Evidence of severe psychiatric illness (e.g. mood disorder with functional impairment or suicide risk, schizophrenia) or medical condition (i.e., hypertension) judged by the study physician (and PI to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent.
  • Current predominant licit use of medical cannabis
  • Current use of prescription or regular use of over the counter medications (with the exception of hormonal contraceptives and hormone replacement therapy). Current use of herbal supplements that may affect study outcomes or interact with study drug (i.e., St Johns wort, kava, L-tryptophan, melatonin)
  • 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
  • Current pain
  • 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.
  • 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.
  • Intolerance to lactose and sesame (ingredients in the oral THC preparation)
  • Insensitivity to the Cold Pressor Test

Lead Scientist at University of California Health

  • Ziva Cooper, PhD (ucla)
    Dr. Ziva Cooper, Ph.D. is the Director of the UCLA Center for Cannabis and Cannabinoids in the Jane and Terry Semel Institute for Neuroscience and Human Behavior and Professor in the UCLA Departments of Psychiatry and Biobehavioral Sciences and Anesthesiology.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT05865470
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 103 study participants
Last Updated