RECRUITING

Evaluating a Potential Pharmacokinetic Kratom-oxycodone Interaction Concurrent With Clinical Endpoints

Conditions

Herbal Interaction pharmacokinetic pharmacokinetics pharmacodynamic pharmacodynamics kratom oxycodone natural product botanical product natural product-drug interaction mitragynine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to investigate whether the botanical product kratom affects how the body processes the opioid drug oxycodone. The main research questions to be answered are two-fold: 1. How does kratom affect the manner in which oxycodone is metabolized (broken down and removed) by the body? 2. Does kratom change the effects oxycodone exerts on the body? Healthy adult participants will complete four study arms, during which they will be given the following: * Kratom (as a tea) * A single dose of oxycodone (as a tablet) * Kratom tea and a single dose of oxycodone * Kratom tea for four days, then kratom tea and a single dose of oxycodone

Official Title

Evaluating a Potential Pharmacokinetic Kratom-oxycodone Interaction Concurrent With Clinical Endpoints

Quick Facts

Study Start:2023-06-01

Study Completion:2025-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05846451

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Males and females, aged from 21-45 years and healthy * Body weight between 130 and 250 pounds (60-115 kg) and body mass index between 19 and 30 * Not taking any medications (prescription and non-prescription) or dietary supplements/botanical products known to alter the pharmacokinetics of either oxycodone or kratom * Willing to abstain from consuming dietary supplements/botanical products and fruit juices for several weeks * Willing to abstain from cannabis/marijuana, hemp, and THC- and/or CBD-containing products for several weeks * Willing to abstain from consuming caffeinated beverages or other caffeine-containing products the evening before and morning of any inpatient visit * Willing to abstain from consuming alcoholic beverages for one day prior to any inpatient visit * Willing to use an additional method of contraception that does not include oral contraceptive pills, patches, or other hormonal methods (such as abstinence, copper IUD, or condoms) * Have consumed kratom previously and tolerated it well without any unpleasant effects * Willing to abstain from kratom for several weeks * Have consumed any opioid previously and tolerated it well without any unpleasant effects or addiction * 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 * Geographically located within a 40-mile radius of Spokane and have the time to participate	* Males and females under the age of 21 or over the age of 45 * People who weigh less than 130 pounds or more than 250 pounds * People with a body mass index less than 19 or greater than 30 * Any current major illness or chronic illness including but not limited to kidney disease, hepatic disease, diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, cancer, or HIV/AIDS * No previous exposure to kratom * No previous exposure to an opioid * History of anemia or any other significant hematologic disorder * History of substance abuse, dependence, or 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) * Pregnant or nursing * History of allergy or intolerance to kratom, other opioids, or oxycodone * Taking concomitant medications, both prescription and non-prescription (including dietary supplements/botanical products), known to alter the pharmacokinetics of kratom or oxycodone * 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 * History of sleep apnea * Any prior use of amphetamines, benzodiazepines, cocaine, MDMA, opioids, PCP, or other drugs for recreational purposes * Use of cannabis/marijuana, hemp, THC-containing products, CBD-containing products, or CBD within the last month * Out-of-range clinical laboratory value that the study physician considers participation in the study a health risk * Inability to speak, read, and understand English

Inclusion Criteria

Exclusion Criteria

* Males and females, aged from 21-45 years and healthy
* Body weight between 130 and 250 pounds (60-115 kg) and body mass index between 19 and 30
* Not taking any medications (prescription and non-prescription) or dietary supplements/botanical products known to alter the pharmacokinetics of either oxycodone or kratom
* Willing to abstain from consuming dietary supplements/botanical products and fruit juices for several weeks
* Willing to abstain from cannabis/marijuana, hemp, and THC- and/or CBD-containing products for several weeks
* Willing to abstain from consuming caffeinated beverages or other caffeine-containing products the evening before and morning of any inpatient visit
* Willing to abstain from consuming alcoholic beverages for one day prior to any inpatient visit
* Willing to use an additional method of contraception that does not include oral contraceptive pills, patches, or other hormonal methods (such as abstinence, copper IUD, or condoms)
* Have consumed kratom previously and tolerated it well without any unpleasant effects
* Willing to abstain from kratom for several weeks
* Have consumed any opioid previously and tolerated it well without any unpleasant effects or addiction
* 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
* Geographically located within a 40-mile radius of Spokane and have the time to participate

* Males and females under the age of 21 or over the age of 45
* People who weigh less than 130 pounds or more than 250 pounds
* People with a body mass index less than 19 or greater than 30
* Any current major illness or chronic illness including but not limited to kidney disease, hepatic disease, diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, cancer, or HIV/AIDS
* No previous exposure to kratom
* No previous exposure to an opioid
* History of anemia or any other significant hematologic disorder
* History of substance abuse, dependence, or 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)
* Pregnant or nursing
* History of allergy or intolerance to kratom, other opioids, or oxycodone
* Taking concomitant medications, both prescription and non-prescription (including dietary supplements/botanical products), known to alter the pharmacokinetics of kratom or oxycodone
* 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
* History of sleep apnea
* Any prior use of amphetamines, benzodiazepines, cocaine, MDMA, opioids, PCP, or other drugs for recreational purposes
* Use of cannabis/marijuana, hemp, THC-containing products, CBD-containing products, or CBD within the last month
* Out-of-range clinical laboratory value that the study physician considers participation in the study a health risk
* Inability to speak, read, and understand English

Contacts and Locations

Study Contact

Mary Paine, PhD

CONTACT

509-358-7759

mary.paine@wsu.edu

Deena Hadi, BS

CONTACT

509-368-6692

deena.hadi@wsu.edu

Study Locations (Sites)

Washington State University College of Pharmacy and Pharmaceutical Sciences

Spokane, Washington, 99202

United States

Collaborators and Investigators

Sponsor: Washington State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-01

Study Completion Date2025-05-01

Study Record Updates

Study Start Date2023-06-01

Study Completion Date2025-05-01

Terms related to this study

Keywords Provided by Researchers

pharmacokinetic
pharmacokinetics
pharmacodynamic
pharmacodynamics
kratom
oxycodone
natural product
botanical product
natural product-drug interaction
mitragynine

Additional Relevant MeSH Terms

Herbal Interaction