Health TrialsbyHealthPanel

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

ConditionInteraction
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21-64
SponsorWashington State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Cannabidiol in the form of hemp

    Drug

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

  • Clopidogrel

    Drug

    75 mg oral clopidogrel

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Arm 1: clopidogrel aloneExperimental treatment 1 intervention
Group B: Arm 2: chronic hemp (30 mg CBD) + clopidogrelExperimental treatment 2 interventions
Group C: Arm 3: chronic hemp (240 mg CBD) + clopidogrelExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

AUC ratio of clopidogrel active metabolite

Ratio of the area under the plasma concentration vs. time curve of the active metabolite of clopidogrel in the presence to absence of hemp

Time frame
0-24 hours

Secondary outcomes

1

Cannabidiol AUC

Area under the plasma concentration vs. time curve of cannabidiol

Time frame
0-72 hours
2

AUC of cannabidiol metabolites

Area under the plasma concentration vs. time curve of cannabidiol metabolites

Time frame
0-72 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington State University

Lead sponsor

Office of Dietary Supplements (ODS)

Collaborator

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov
Apply now