Actively Recruiting

Early Phase 1
Age: 21Years - 64Years
All Genders
Healthy Volunteers
NCT06692933

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

Led by Washington State University · Updated on 2024-11-18

24

Participants Needed

1

Research Sites

79 weeks

Total Duration

On this page

Sponsors

W

Washington State University

Lead Sponsor

O

Office of Dietary Supplements (ODS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years - 64Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 21 and 64 years and healthy
  • Confirmed by genetic test as a CYP2C19 normal, rapid, or ultra-rapid metabolizer
  • Not taking medications or supplements known to affect cannabis or clopidogrel metabolism
  • Have previously used hemp or cannabis and tolerated it well
  • Willing to abstain from supplements, botanical products, and citrus juices during the study
  • Willing to avoid cannabis, hemp, THC, and CBD products for several weeks
  • Willing to avoid caffeine the evening before and morning of inpatient days
  • Willing to avoid alcohol for one day before inpatient days
  • Willing to use a non-hormonal secondary birth control method during and for one week after the study
  • Able and willing to comply with study requirements
  • Located within 40 miles of Spokane and able to participate
  • Can read and speak English
Not Eligible

You will not qualify if you...

  • Younger than 21 or older than 64 years
  • Have any major illness
  • Pregnant or nursing
  • Allergy or intolerance to cannabis or clopidogrel
  • Taking medications or supplements affecting cannabis or clopidogrel metabolism
  • Never used cannabis in any form
  • Any condition posing safety risks or affecting data quality
  • Currently using or recently used illicit drugs for recreation
  • Used cannabis, hemp, THC, or CBD products within the last 4 weeks
  • Abnormal lab values posing health risks
  • Unable to read and speak English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Washington State University College of Pharmacy and Pharmaceutical Sciences

Spokane, Washington, United States, 99202

Actively Recruiting

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Research Team

M

Mary F Paine, RPh, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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