Evaluating a Potential Pharmacokinetic Kratom-oxycodone Interaction Concurrent With Clinical Endp… (NCT05846451) | Clinical Trial Compass
RecruitingEarly Phase 1
Evaluating a Potential Pharmacokinetic Kratom-oxycodone Interaction Concurrent With Clinical Endpoints
United States16 participantsStarted 2023-06-01
Plain-language summary
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
Who can participate
Age range
21 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 pa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oxycodone area under the concentration vs. time curve (AUC) ratio (presence to absence of kratom)