CBD study in 24 healthy volunteers reveals how the body absorbs it
NCT ID NCT05023070
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This completed Phase 1 trial looked at how cannabidiol (CBD) is absorbed and processed in 24 healthy adults. Researchers gave different doses of CBD and measured its levels in blood and urine, along with any side effects. The goal was to understand the drug's pharmacokinetics, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cannabidiol (CBD)
- What this could lead to
- If successful, this could help doctors understand the best way to dose CBD for future studies or medical use.
- What could go wrong
- This is a very early, small study in healthy people, not patients. It only looks at how the body handles CBD, not whether it treats any disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
24 people
The number who actually took part.
- Started
-
Jul 2021
- Finished
-
Feb 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Ability to understand and give informed consent; 2. Individuals between 18 and 65 years old; Sex is used a biological factor (50% of individuals recruited will be females, allowing sex comparisons). 3. English speakers. 4. Being healthy as determined by study physician according to screening medical and psychiatric history, physical examination, vitals, ECG and safety laboratory values. Only healthy volunteers with normal hepatic laboratory values will be enrolled. 5. Healthy volunteers who are medication- and drug-free, including free from nicotine and any prescribed medications. Exclusion Criteria: 1. Having present or past medical conditions, including a DSM-5 Axis I psychiatric disorder, history of cardiac disease, arrhythmias, neurological disease of central origin, head trauma, and seizures 2. Using any psychoactive drug (other than nicotine) in at least the past 7 days (determined by lack of acute-opioid or other drugs related withdrawal symptoms and the negative result of a urine drug screen including an opioid drug metabolite test, and alcohol breathalyzer to detect alcohol intoxication); 3. Positive urine drug screen (cocaine, opiates, benzodiazepines, barbiturates, amphetamines, morphine, methadone, methamphetamines, oxycodone, phencyclidine, tricyclic antidepressant, tetrahydrocannabinol, buprenorphine, methylenedioxymethamphetamine, propoxyphene); 4. Having a history of hypersensitivity to cannabinoids or any of the ingredients in the product (gelatin and/or sesame oil); 5. Being pregnant or breastfeeding; 6. Not using an appropriate method of contraception such as hormonal contraception (oral hormonal contraceptives, Depo-Provera, Nuva-Ring), intrauterine device (IUD), sterilization, or double barrier method (combination of any two barrier methods used simultaneously, i.e. condom, spermicide, diaphragm); 7. Participating in another pharmacotherapeutic trial in the past 3 months; 8. History of impaired renal function or elevated liver enzymes at prescreening. The exclusionary lab values are: 3x nl AST/ALT, 1.5x bilirubin or 50% reduction in eGFR. 9. Participants who have used any medication, dietary supplements (and/or grape fruit juice), or combination of medications and supplements known to alter the metabolism of, or interact with CBD (bupropion, rifampin, barbiturates, phenothiazines, cimetidine, etc.) 14 days prior to and during the duration of the study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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