Effects of a hemp product on clopidogrel levels in the body

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Mary F Paine, RPh, PhD
• Email: mary.paine@wsu.edu
• Phone: 509-358-7759

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.