InteractionEarly Phase 1NCT06692933
Effects of a Hemp Product on the Pharmacokinetics and Pharmacodynamics of Clopidogrel
A Early Phase 1 study testing Cannabidiol in the form of hemp and Clopidogrel in people with Interaction, run by Washington State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine how two different doses of cannabidiol (CBD), given as a hemp product, change the blood concentrations of the drug clopidogrel in the body. Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Interaction
- What is being tested?
- Cannabidiol in the form of hemp and Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2024to 31 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-64 years old and healthy;
- Confirmed by genetic test to be a CYP2C19 normal, rapid, or ultra-rapid metabolizer;
- Not taking any medications (prescription and non-prescription, including clopidogrel) or dietary supplements/botanical products known to alter the pharmacokinetics of cannabis and/or clopidogrel;
- Have taken hemp or cannabis (in any form) before and tolerated it well;
- Willing to abstain from consuming dietary supplements/botanical products and citrus juices for the duration of the study;
- Willing to abstain from cannabis/marijuana, hemp, THC- and/or CBD-containing products for several weeks;
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- Willing to abstain from consuming caffeinated beverages or other caffeine-containing products the evening before and morning of any inpatient day;
- Willing to abstain from consuming alcoholic beverages for one day prior to any inpatient day;
- Willing to use a secondary method of birth control that does not include the introduction or discontinuance of hormonal-based birth control (such as abstinence, copper IUD, or condoms), continuing for 1 week after completing the study;
- Have the ability to and are willing to comply with the requirements of the study;
- Geographically located within a 40-mile radius of Spokane and have the time to participate and;
- Can read and speak English
Who cannot join
- Under the age of 21 or over the age of 64;
- Any major illness;
- Pregnant or nursing;
- History of allergy or intolerance to cannabis or clopidogrel;
- Taking concomitant medications, both prescription and non-prescription (including clopidogrel) or dietary supplements/botanical products known to alter the pharmacokinetics of cannabis and/or clopidogrel;
- Never taken cannabis (in any form) before;
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- Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise participant safety or the quality of the data;
- Currently using or have recently used drugs or other illicit substances for recreational purposes;
- Have used cannabis/marijuana, hemp, THC- and/or CBD-containing products within the last 4 weeks;
- Have an out-of-range clinical laboratory value such that the study physician considers participation in the study a health risk, or;
- Unable to read and speak English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington State University College of Pharmacy and Pharmaceutical Sciences
Spokane, Washington, 99202
Mary F Paine, RPh, PhD, 509-358-7759, mary.paine@wsu.edu
Mary F Paine, RPh, PhD
About this study
The goal of this clinical trial is to determine how two different doses of cannabidiol (CBD), given as a hemp product, change the blood concentrations of the drug clopidogrel in the body. Results will be used to help design future studies and to assist healthcare providers in informing their patients about the safe use of CBD.
Read the detailed description
The popularity of cannabis products has grown exponentially over the past decade as several states continue to decriminalize or legalize recreational and/or medicinal use. Cannabis contains >500 phytoconstituents, including >100 cannabinoids. The most well-studied cannabinoids are tetrahydrocannabinol (THC) and cannabidiol (CBD). Although both are psychoactive, THC produces the characteristic "high," while CBD does not. CBD is available as a prescription drug (Epidiolex®) to treat seizure disorders. Hemp, a popular CBD-containing botanical product, is defined as containing <0.3% THC. Hemp was federally legalized in the United States in 2018 following passage of the Farm Bill. Since passage of that bill, hemp and other CBD-containing products have become widely available over the counter. As such, hemp/CBD products have become top-selling botanicals, with sales projected to reach nearly $4.5 billion by 2024. Common uses include self-treatment for pain, anxiety, and sleep disorders.
Despite increasing use of cannabis products, the pharmacokinetic interaction potential with pharmaceutical medications remains understudied. Previous pharmacokinetic studies have yielded convincing evidence that CBD significantly inhibits the activity of the drug metabolizing enzyme cytochrome P450 (CYP) 2C19. Despite the valuable information generated by these and numerous other studies, several unanswered questions about CBD-containing products remain:
- Do real-world doses and dosing regimens of CBD (< 300 mg) have similar CYP interaction potential as that of higher doses investigated in previous pharmacokinetic studies?
- What are the effects of CBD on high-impact CYP2C19 substrates, such as the anti-platelet drug clopidogrel (Plavix®)?
- Does chronic administration of a real-world dose of CBD have similar interaction potential as a very high single dose of CBD?
The primary objective of the proposed study is to evaluate the effects of a well-characterized, widely used hemp product on the pharmacokinetics of the commonly prescribed CYP2C19 substrate clopidogrel (Plavix®) in healthy adult participants who are confirmed to be CYP2C19 normal, rapid, or ultra-rapid metabolizers. Results could be used to inform a future study design involving elderly people, which is a population of interest. Results could also be used to guide healthcare providers in helping their patients make informed decisions about the safe use of hemp
- Conditions
- Interaction
- Being tested
- Cannabidiol in the form of hemp, Clopidogrel
- Keywords
- CYP2C19, pharmacokinetics, hemp, CBD, natural product, clopidogrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol in the form of hempDrug
Also called CBD
Cannabidiol (30 mg) in the form of an orally administered hemp oil softgel
ClopidogrelDrug
Also called Plavix
75 mg oral clopidogrel
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: clopidogrel alone | Experimental | Participants will be administered a single oral dose (75 mg) of clopidogrel. Blood and urine will be collected for 24 hours. Receives: Drug: Clopidogrel |
| Arm 2: chronic hemp (30 mg CBD) + clopidogrel | Experimental | Participants will self-administer a single low dose of hemp (30 mg CBD) as an oral softgel at home daily for 5 consecutive days. On day 6, participants will return to the research setting, where they will be administered a single low dose of hemp (30 mg CBD) and a single oral dose of clopidogrel (75 mg). Blood will be collected for 72 hours and urine will be collected for 24 hours. Receives: Drug: Cannabidiol in the form of hemp; Drug: Clopidogrel |
| Arm 3: chronic hemp (240 mg CBD) + clopidogrel | Experimental | Participants will repeat the Arm 2 procedures using a higher dose of hemp (240 mg CBD) Receives: Drug: Cannabidiol in the form of hemp; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC ratio of clopidogrel active metabolite
Ratio of the area under the plasma concentration vs. time curve of the active metabolite of clopidogrel in the presence to absence of hemp
Measured: 0-24 hours
Secondary outcomes (2)
Cannabidiol AUC
Area under the plasma concentration vs. time curve of cannabidiol
Measured: 0-72 hours
AUC of cannabidiol metabolites
Area under the plasma concentration vs. time curve of cannabidiol metabolites
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start20 Jun 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- Office of Dietary Supplements (ODS), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Mary Paine, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692933
- Sponsor's protocol ID
- 20533
- Other IDs
- U54AT008909
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Hemp Product on the Pharmacokinetics and Pharmacodynamics of Clopidogrel
- ClinicalTrials.gov ID
- NCT06692933
- Acronym / sponsor ID
- 20533
- Conditions
- Interaction
- Keywords
- CYP2C19, pharmacokinetics, hemp, CBD, natural product, clopidogrel
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- Office of Dietary Supplements (ODS), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine how two different doses of cannabidiol (CBD), given as a hemp product, change the blood concentrations of the drug clopidogrel in the body. Results will be used to help design future studies and to assist healthcare providers in informing their patients about the safe use of CBD.
Detailed description
The popularity of cannabis products has grown exponentially over the past decade as several states continue to decriminalize or legalize recreational and/or medicinal use. Cannabis contains >500 phytoconstituents, including >100 cannabinoids. The most well-studied cannabinoids are tetrahydrocannabinol (THC) and cannabidiol (CBD). Although both are psychoactive, THC produces the characteristic "high," while CBD does not. CBD is available as a prescription drug (Epidiolex®) to treat seizure disorders. Hemp, a popular CBD-containing botanical product, is defined as containing <0.3% THC. Hemp was federally legalized in the United States in 2018 following passage of the Farm Bill. Since passage of that bill, hemp and other CBD-containing products have become widely available over the counter. As such, hemp/CBD products have become top-selling botanicals, with sales projected to reach nearly $4.5 billion by 2024. Common uses include self-treatment for pain, anxiety, and sleep disorders.
Despite increasing use of cannabis products, the pharmacokinetic interaction potential with pharmaceutical medications remains understudied. Previous pharmacokinetic studies have yielded convincing evidence that CBD significantly inhibits the activity of the drug metabolizing enzyme cytochrome P450 (CYP) 2C19. Despite the valuable information generated by these and numerous other studies, several unanswered questions about CBD-containing products remain:
- Do real-world doses and dosing regimens of CBD (< 300 mg) have similar CYP interaction potential as that of higher doses investigated in previous pharmacokinetic studies?
- What are the effects of CBD on high-impact CYP2C19 substrates, such as the anti-platelet drug clopidogrel (Plavix®)?
- Does chronic administration of a real-world dose of CBD have similar interaction potential as a very high single dose of CBD?
The primary objective of the proposed study is to evaluate the effects of a well-characterized, widely used hemp product on the pharmacokinetics of the commonly prescribed CYP2C19 substrate clopidogrel (Plavix®) in healthy adult participants who are confirmed to be CYP2C19 normal, rapid, or ultra-rapid metabolizers. Results could be used to inform a future study design involving elderly people, which is a population of interest. Results could also be used to guide healthcare providers in helping their patients make informed decisions about the safe use of hemp
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: clopidogrel alone | Experimental | Drug: ClopidogrelParticipants will be administered a single oral dose (75 mg) of clopidogrel. Blood and urine will be collected for 24 hours. |
| Arm 2: chronic hemp (30 mg CBD) + clopidogrel | Experimental | Drug: Cannabidiol in the form of hemp, Drug: ClopidogrelParticipants will self-administer a single low dose of hemp (30 mg CBD) as an oral softgel at home daily for 5 consecutive days. On day 6, participants will return to the research setting, where they will be administered a single low dose of hemp (30 mg CBD) and a single oral dose of clopidogrel (75 mg). Blood will be collected for 72 hours and urine will be collected for 24 hours. |
| Arm 3: chronic hemp (240 mg CBD) + clopidogrel | Experimental | Drug: Cannabidiol in the form of hemp, Drug: ClopidogrelParticipants will repeat the Arm 2 procedures using a higher dose of hemp (240 mg CBD) |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 21-64 years old and healthy;
- Confirmed by genetic test to be a CYP2C19 normal, rapid, or ultra-rapid metabolizer;
- Not taking any medications (prescription and non-prescription, including clopidogrel) or dietary supplements/botanical products known to alter the pharmacokinetics of cannabis and/or clopidogrel;
- Have taken hemp or cannabis (in any form) before and tolerated it well;
- Willing to abstain from consuming dietary supplements/botanical products and citrus juices for the duration of the study;
Key exclusion criteria (11 listed)
- Under the age of 21 or over the age of 64;
- Any major illness;
- Pregnant or nursing;
- History of allergy or intolerance to cannabis or clopidogrel;
- Taking concomitant medications, both prescription and non-prescription (including clopidogrel) or dietary supplements/botanical products known to alter the pharmacokinetics of cannabis and/or clopidogrel;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol in the form of hempAlso: CBDCannabidiol (30 mg) in the form of an orally administered hemp oil softgel | Drug | Arm 2: chronic hemp (30 mg CBD) + clopidogrel, Arm 3: chronic hemp (240 mg CBD) + clopidogrel |
| ClopidogrelAlso: Plavix75 mg oral clopidogrel | Drug | Arm 1: clopidogrel alone, Arm 2: chronic hemp (30 mg CBD) + clopidogrel, Arm 3: chronic hemp (240 mg CBD) + clopidogrel |
Primary outcome
AUC ratio of clopidogrel active metabolite
Time frame: 0-24 hours
Ratio of the area under the plasma concentration vs. time curve of the active metabolite of clopidogrel in the presence to absence of hemp
2 secondary outcomes
Cannabidiol AUC
Time frame: 0-72 hours
AUC of cannabidiol metabolites
Time frame: 0-72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes. IPD used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cannabidiol in the form of hemp and Clopidogrel in people with Interaction, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary F Paine, RPh, PhD (509-358-7759, mary.paine@wsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC ratio of clopidogrel active metabolite (time frame: 0-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.