Clinical trial NCT05067387: Evaluation of Oral THC and CBD in Men and Women
Official title: Evaluation of Oral THC and CBD in Oral Fluid, Pharmacokinetics, and Subjective and Neurocognitive Effects in Men and Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Drug Abuse
Intoxication by Drug
Impairment
Keywords: THC
CBD
Intoxication
Impairment
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

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.

Primary outcomes:
measure: Ratings of subjective drug effects
timeFrame: 6 hours
measure: Concentration of THC, CBD and metabolites in whole blood
timeFrame: 6 hours
measure: Behavioral task performance as assessed by the DRUID App Score
timeFrame: 6 hours
measure: Concentration of THC in oral fluid
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Ziva Cooper
role: PRINCIPAL_INVESTIGATOR
References: