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NCT05067387
Evaluation of Oral THC and CBD in Men and Women
Conditions: Drug Abuse, Intoxication by Drug, Impairment
Sex: All
Ages: 21 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 22
Sponsor: University of California, Los Angeles
Location: University of California, Los Angeles Los Angeles California
Summary
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.
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.
Source: ClinicalTrials.gov (NCT05067387). StuddyBuddy aggregates publicly available trial information.