Effects of a hemp product on clopidogrel levels in the body

Effects of a Hemp Product on the Pharmacokinetics and Pharmacodynamics of Clopidogrel

This study is testing how different amounts of CBD from hemp affect the levels of the blood thinner clopidogrel in healthy adults aged 21-64.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 21 Years to 64 Years
• Sex: All
• Sponsor: Washington State University (Academic / other)
• Locations: 1 site (Spokane, Washington)
• Trial ID: NCT06692933 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to investigate how different doses of cannabidiol (CBD), derived from hemp, influence the blood concentrations of the medication clopidogrel. The study will involve healthy participants aged 21-64 who are confirmed to be normal, rapid, or ultra-rapid metabolizers of the CYP2C19 enzyme. Participants will be required to abstain from various substances that could affect the study's outcomes. The findings will help inform healthcare providers about the safe use of CBD alongside clopidogrel and guide future research in this area.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 21-64 who are confirmed CYP2C19 normal, rapid, or ultra-rapid metabolizers.

Not a fit: Patients who are not CYP2C19 metabolizers or those taking medications that alter the pharmacokinetics of cannabis or clopidogrel may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safe co-administration of CBD and clopidogrel, potentially improving patient care.

How similar studies have performed: While there is limited research on the interaction between CBD and clopidogrel, previous studies have shown that CBD can significantly inhibit the CYP2C19 enzyme, indicating a potential area of concern that this study aims to address.

Eligibility criteria

Inclusion Criteria:

* 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;
* 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

Exclusion Criteria:

* 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;
* 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

Where this trial is running

Spokane, Washington

• Washington State University College of Pharmacy and Pharmaceutical Sciences — Spokane, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Mary F Paine, RPh, PhD

Conditions Interaction; CYP2C19; pharmacokinetics; hemp; CBD; natural product; clopidogrel