RECRUITING

Evaluation of Smoked THC and CBD in Men and Women

Conditions

Drug Abuse Intoxication by Drug Impairment Cannabis THC CBD Intoxication

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-09-01

Study Completion:2026-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05037487

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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)	* 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.

Inclusion Criteria

Exclusion 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)

* 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.

Contacts and Locations

Study Contact

Ziva Cooper, PhD

CONTACT

310-206-9942

zcooper@mednet.ucla.edu

Principal Investigator

Ziva Cooper, PhD

PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Study Locations (Sites)

University of California, Los Angeles

Los Angeles, California, 90095

United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Ziva Cooper, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-01

Study Completion Date2026-03-01

Study Record Updates

Study Start Date2022-09-01

Study Completion Date2026-03-01

Terms related to this study

Keywords Provided by Researchers

Cannabis
THC
CBD
Intoxication
Impairment

Additional Relevant MeSH Terms

Drug Abuse
Intoxication by Drug
Impairment