NCT05067387 · University of California, Los Angeles
Evaluation of Oral THC and CBD in Men and Women
(O-TACOFS)
What this study is about
The purpose of this study is to determine the how the drug moves through the body and how the drug affects the body of taken by mouth delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and to evaluate detection of recently smoked THC in taken by mouth fluid.
View original scientific description
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.
Interventions
DRUG
Placebo
Oral placebo
DRUG
THC
Oral THC (20 mg)
DRUG
CBD
Oral CBD (20 mg)
DRUG
THC + CBD
Oral THC (20 mg) + CBD (20 mg)
Primary outcome measures
Ratings of subjective drug effects
Time frame: 6 hours
Average and peak subjective ratings of drug effects associated with abuse liability as measured using visual analogue scales (VAS; 1-100mm).
Concentration of THC, CBD and metabolites in whole blood
Time frame: 6 hours
Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH as measured in ng/ml
Behavioral task performance as assessed by the DRUID App Score
Time frame: 6 hours
Composite score on the DRUID App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance
Concentration of THC in oral fluid
Time frame: 6 hours
Liquid chromatography-tandem mass spectrometry
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 8, 2026 · Source of record for eligibility and locations