RECRUITING

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

Conditions

Interaction CYP2C19 pharmacokinetics hemp CBD natural product clopidogrel

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-20

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06692933

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Mary F Paine, RPh, PhD

CONTACT

509-358-7759

mary.paine@wsu.edu

Study Locations (Sites)

Washington State University College of Pharmacy and Pharmaceutical Sciences

Spokane, Washington, 99202

United States

Collaborators and Investigators

Sponsor: Washington State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-20

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-06-20

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

CYP2C19
pharmacokinetics
hemp
CBD
natural product
clopidogrel

Additional Relevant MeSH Terms

Interaction