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Cannabinoid

Hemp Product for Drug Interactions

Phase < 1

Recruiting

Research Sponsored by Washington State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not taking any medications or dietary supplements known to alter the pharmacokinetics of cannabis and/or clopidogrel

Confirmed by genetic test to be a CYP2C19 normal, rapid, or ultra-rapid metabolizer

Must not have

Unable to read and speak English

Under the age of 21 or over the age of 64

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-72 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how two different doses of CBD, given in a hemp product, affect the levels of the drug clopidogrel in the blood. The findings will guide future research and help

Who is the study for?

This trial is for individuals who are currently taking the drug clopidogrel. Participants should not have any health conditions that could interfere with the study or be using other medications that might affect how clopidogrel works in their body.

What is being tested?

The study is testing how two different doses of cannabidiol (CBD), delivered as a hemp product, impact the levels and effects of clopidogrel in the bloodstream.

What are the potential side effects?

Potential side effects may include changes in liver enzyme levels, fatigue, changes in appetite, gastrointestinal discomfort, and mood alterations. The full range of side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not on medications or supplements that affect how cannabis or clopidogrel works in my body.

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My genetic test shows I metabolize certain drugs normally or very quickly.

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I am between 21 and 64 years old and in good health.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot read or speak English.

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I am either younger than 21 or older than 64.

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I have used cannabis or related products in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUC ratio of clopidogrel active metabolite

Secondary study objectives

AUC of cannabidiol metabolites

Cannabidiol AUC

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm 3: chronic hemp (240 mg CBD) + clopidogrelExperimental Treatment2 Interventions

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

Group II: Arm 2: chronic hemp (30 mg CBD) + clopidogrelExperimental Treatment2 Interventions

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.

Group III: Arm 1: clopidogrel aloneExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Clopidogrel

2010

Completed Phase 4

~9160

0 / 6Eligibility criteria met