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

Part of paid clinical trials in Spokane, Washington.

Sponsor
Washington State University
Study ID
NCT06692933
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Interaction

Eligibility Criteria

Sex
ALL
Age
21 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jun 20, 2024
Status verified
Jun 2026
Primary completion
Aug 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

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)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington State University College of Pharmacy and Pharmaceutical SciencesSpokaneWashington99202
Mary F Paine, RPh, PhD
[email protected]
509-358-7759
Mary F Paine, RPh, PhD (PRINCIPAL_INVESTIGATOR)
Matthew Layton, MD, PhD (SUB_INVESTIGATOR)
John White, PharmD, PA-C (SUB_INVESTIGATOR)

Find similar trials in Spokane, WA

By research site
Washington State University College of Pharmacy and Pharmaceutical Sciences· Spokane, WA

Related Studies