Status:
COMPLETED
Assessing the Pharmacokinetics and Drug Interaction Liability of Kratom, an Opioid-like Natural Product
Lead Sponsor:
Washington State University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Interaction Drug Food
Eligibility:
All Genders
18-55 years
Phase:
EARLY_PHASE1
Brief Summary
Kratom is a botanical natural product that has opioid-like effects. Kratom is commonly used to self-treat withdrawal symptoms associated with opioid addiction, as well as pain. Kratom products include...
Detailed Description
Many patient groups often supplement their drug regimens with herbal and other natural products (NPs), raising concern for adverse NP-drug interactions. Due to a lack of rigorous guidelines for assess...
Eligibility Criteria
Inclusion
- Not taking any medications (prescription and non-prescription) or dietary/herbal supplements known to alter the pharmacokinetics of either study drug or kratom constituents
- Willing to abstain from consuming dietary/herbal supplements, including kratom, and citrus juices for several weeks
- Willing to abstain from consuming caffeinated beverages or other caffeine-containing products the evening before and morning of the first day of a study arm
- Willing to abstain from consuming any alcoholic beverages for one day prior to any study day, during the 14-hour inpatient days, and for the 5 and/or 1 outpatient visit(s) following 14-hour visit
- Willing to use an acceptable method of contraception that does not include oral contraceptive pills or patches (such as abstinence, copper IUD, condom)
- Have the time to participate
- Are non-naïve kratom users (intermittent users who are not trying to quit but willing to abstain for several weeks)
- Carry a CYP2D6 genotype designated as having an intermediate, extensive, or ultra-extensive metabolizer phenotype
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for the subject to comply with the requirements of the study
Exclusion
- Men and women under the age of 18 or over the age of 55
- Unwilling to abstain from kratom for several weeks
- Any current major illness or chronic illness such as (but not limited to) kidney disease, hepatic disease, diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, cancer, or HIV/AIDS
- History of anemia or any other significant hematologic disorder
- History of drug or alcohol addiction or major psychiatric illness
- A need for chronic opioid analgesics
- Use of opioid analgesics 3 weeks prior to initiation of the study
- An imminent likely need for opioid analgesics (e.g., planned dental or surgical procedure)
- Female and pregnant or nursing
- Have a history of allergy to dextromethorphan, midazolam, or related drugs
- Have a history of intolerance or allergy to kratom or opioids
- Taking concomitant medications, both prescription and non-prescription (including dietary supplements/herbal products), known to alter the pharmacokinetics of either study drug or kratom constituents
- Carry a CYP2D6 genotype designated as having a poor metabolizer phenotype
- Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data
Key Trial Info
Start Date :
October 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04392011
Start Date
October 9 2019
End Date
August 31 2021
Last Update
December 20 2023
Active Locations (1)
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1
Washington State University College of Pharmacy and Pharmaceutical Sciences
Spokane, Washington, United States, 99202