Recruiting
Early Phase 1

Hemp with Clopidogrel

Sponsor:

Washington State University

Code:

NCT06692933

Conditions

Interaction

Eligibility Criteria

Sex: All

Age: 21 - 64

Healthy Volunteers: Accepted

Interventions

Cannabidiol in the form of hemp

Clopidogrel

Study Details

Brief summary:

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

Interaction

Study ID

NCT06692933

Start date

Jun 20, 2024

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 64

Healthy Volunteers: Accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Arm 1: clopidogrel alone

Participants will be administered a single oral dose (75 mg) of clopidogrel. Blood and urine will be collected for 24 hours.

experimental: Arm 2: chronic hemp (30 mg CBD) + clopidogrel

Participants will self-administer a single low dose of hemp (30 mg CBD) as an oral softgel at home daily for 5 consecutive days. On day 6, participants will return to the research setting, where they will be administered a single low dose of hemp (30 mg CBD) and a single oral dose of clopidogrel (75 mg). Blood will be collected for 72 hours and urine will be collected for 24 hours.

experimental: Arm 3: chronic hemp (240 mg CBD) + clopidogrel

Participants will repeat the Arm 2 procedures using a higher dose of hemp (240 mg CBD)

Interventions

Cannabidiol in the form of hemp

Cannabidiol (30 mg) in the form of an orally administered hemp oil softgel

Clopidogrel

75 mg oral clopidogrel

Primary outcome measure

  • AUC ratio of clopidogrel active metabolite [ Time Frame: 0-24 hours ]

Central Contacts and Locations

Central contacts

Mary F Paine, RPh, PhD

509-358-7759mary.paine@wsu.edu

Locations

Washington State University College of Pharmacy and Pharmaceutical Sciences

Recruiting

Spokane, Washington, United States, 99202

Contacts

Mary F Paine, RPh, PhD

509-358-7759mary.paine@wsu.edu

Principal Investigator:

Mary F Paine, RPh, PhD

More Information

Sponsor

Washington State University

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • CYP2C19
  • pharmacokinetics
  • hemp
  • CBD
  • natural product
  • clopidogrel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Washington State University on 2026-06-04.