Drug Abuse Clinical Trial
— O-TACOFSOfficial title:
Evaluation of Oral THC and CBD in Oral Fluid, Pharmacokinetics, and Subjective and Neurocognitive Effects in Men and Women
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.
Status | Not yet recruiting |
Enrollment | 22 |
Est. completion date | March 2026 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ratings of subjective drug effects | Average and peak subjective ratings of drug effects associated with abuse liability as measured using visual analogue scales (VAS; 1-100mm). | 6 hours | |
Primary | Concentration of THC, CBD and metabolites in whole blood | Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH as measured in ng/ml | 6 hours | |
Primary | Behavioral task performance as assessed by the DRUID App Score | Composite score on the DRUID App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance | 6 hours | |
Primary | Concentration of THC in oral fluid | Liquid chromatography-tandem mass spectrometry | 6 hours |
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