Effects of a Hemp Product on the Pharmacokinetics and Pharmacodynamics of Clopidogrel
Recruiting
Early Phase 1Interventional Study
Interaction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 – 64
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
24 (estimated)
Sponsor
Washington State University · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
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 pharmacokine…
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
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