Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-29 @ 3:55 AM
Study NCT ID:
NCT06692933
Status:
RECRUITING
Last Update Posted:
2024-11-18
First Post:
2024-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Hemp Product on the Pharmacokinetics and Pharmacodynamics of Clopidogrel
Sponsor:
Washington State University
Organization:
Study Overview
Official Title:
Effects of a Hemp Product on the Pharmacokinetics and Pharmacodynamics of Clopidogrel
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
The popularity of cannabis products has grown exponentially over the past decade as several states continue to decriminalize or legalize recreational and/or medicinal use. Cannabis contains \>500 phytoconstituents, including \>100 cannabinoids. The most well-studied cannabinoids are tetrahydrocannabinol (THC) and cannabidiol (CBD). Although both are psychoactive, THC produces the characteristic "high," while CBD does not. CBD is available as a prescription drug (Epidiolex®) to treat seizure disorders. Hemp, a popular CBD-containing botanical product, is defined as containing \<0.3% THC. Hemp was federally legalized in the United States in 2018 following passage of the Farm Bill. Since passage of that bill, hemp and other CBD-containing products have become widely available over the counter. As such, hemp/CBD products have become top-selling botanicals, with sales projected to reach nearly $4.5 billion by 2024. Common uses include self-treatment for pain, anxiety, and sleep disorders.
Despite increasing use of cannabis products, the pharmacokinetic interaction potential with pharmaceutical medications remains understudied. Previous pharmacokinetic studies have yielded convincing evidence that CBD significantly inhibits the activity of the drug metabolizing enzyme cytochrome P450 (CYP) 2C19. Despite the valuable information generated by these and numerous other studies, several unanswered questions about CBD-containing products remain:
1. Do real-world doses and dosing regimens of CBD (\< 300 mg) have similar CYP interaction potential as that of higher doses investigated in previous pharmacokinetic studies?
2. What are the effects of CBD on high-impact CYP2C19 substrates, such as the anti-platelet drug clopidogrel (Plavix®)?
3. Does chronic administration of a real-world dose of CBD have similar interaction potential as a very high single dose of CBD?
The primary objective of the proposed study is to evaluate the effects of a well-characterized, widely used hemp product on the pharmacokinetics of the commonly prescribed CYP2C19 substrate clopidogrel (Plavix®) in healthy adult participants who are confirmed to be CYP2C19 normal, rapid, or ultra-rapid metabolizers. Results could be used to inform a future study design involving elderly people, which is a population of interest. Results could also be used to guide healthcare providers in helping their patients make informed decisions about the safe use of hemp
Despite increasing use of cannabis products, the pharmacokinetic interaction potential with pharmaceutical medications remains understudied. Previous pharmacokinetic studies have yielded convincing evidence that CBD significantly inhibits the activity of the drug metabolizing enzyme cytochrome P450 (CYP) 2C19. Despite the valuable information generated by these and numerous other studies, several unanswered questions about CBD-containing products remain:
1. Do real-world doses and dosing regimens of CBD (\< 300 mg) have similar CYP interaction potential as that of higher doses investigated in previous pharmacokinetic studies?
2. What are the effects of CBD on high-impact CYP2C19 substrates, such as the anti-platelet drug clopidogrel (Plavix®)?
3. Does chronic administration of a real-world dose of CBD have similar interaction potential as a very high single dose of CBD?
The primary objective of the proposed study is to evaluate the effects of a well-characterized, widely used hemp product on the pharmacokinetics of the commonly prescribed CYP2C19 substrate clopidogrel (Plavix®) in healthy adult participants who are confirmed to be CYP2C19 normal, rapid, or ultra-rapid metabolizers. Results could be used to inform a future study design involving elderly people, which is a population of interest. Results could also be used to guide healthcare providers in helping their patients make informed decisions about the safe use of hemp
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U54AT008909 | NIH | None | https://reporter.nih.gov/quic… | View |