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Kratom-Oxycodone Interaction Study for Herbal Interaction
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-24 hours
Awards & highlights
Summary
This trial is studying how kratom tea affects the body's processing and response to the pain medication oxycodone. Healthy adults will take kratom tea and oxycodone in different combinations. Researchers aim to see if kratom changes how oxycodone is broken down and its effects on the body. Kratom is a herb with a long history of traditional use in Southeast Asia, known for its stimulant properties at low doses and effects similar to opioids at higher doses.
Who is the study for?
This trial is for healthy adults aged 21-45, weighing between 130-250 pounds with a BMI of 19-30. Participants must have previously used kratom and opioids without issues or addiction, not be on medications that affect these substances' metabolism, and agree to avoid certain substances like caffeine, alcohol, cannabis products, and dietary supplements before visits.
What is being tested?
The study aims to see if kratom affects how the body processes oxycodone. Participants will try four different scenarios: only kratom tea; just an oxycodone tablet; both together; and several days of kratom followed by both. Researchers want to know how this combination impacts drug metabolism and effects on the body.
What are the potential side effects?
Potential side effects may include typical opioid-related symptoms such as nausea, drowsiness, constipation or itching due to oxycodone. Kratom might cause similar effects including dry mouth, increased urination, loss of appetite or agitation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-24 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Oxycodone area under the concentration vs. time curve (AUC) ratio (presence to absence of kratom)
Secondary study objectives
Area under the pupil diameter (effect) vs. time curve (AUEC) ratio
Oxycodone half-life ratio (presence to absence of kratom)
Oxycodone maximum plasma concentration (Cmax) ratio (presence to absence of kratom)
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm 4Experimental Treatment2 Interventions
The same 16 participants will self-administer a single low dose (2 g) of kratom as a tea once daily at home. On the fifth day, subjects will return to the research setting, where they will be administered a single low dose (2 g) of kratom, followed 15 minutes later by a single low dose (10 mg) of oxycodone by mouth. Plasma, pupil diameter measurements, and urine will be collected from 0-24 hours.
Group II: Arm 3Experimental Treatment2 Interventions
The same 16 participants will be administered a single low dose (2 g) of kratom as a tea. After 15 minutes, the subjects will be administered a single low dose (10 mg) of oxycodone as a tablet by mouth. Plasma, pupil diameter measurements, and urine will be collected from 0-24 hours. A washout of at least 10 days will separate Arms 3 and 4.
Group III: Arm 1Experimental Treatment1 Intervention
Sixteen non-naive\* participants (8 males, 8 females) will be administered a single low dose (2 g) of a well-characterized kratom product by mouth as a tea. Pupil diameter will be measured from 0-12 hours. A washout of at least 10 days will separate Arms 1 and 2.
\*Non-naive subjects are defined as intermittent users who consume 2-8 g kratom at least once per month but no more than three times daily within the last six months prior to screening and are willing to abstain for several weeks
Group IV: Arm 2Active Control1 Intervention
The same 16 participants will be administered a single low dose (10 mg) of immediate-release oxycodone by mouth as a tablet. Plasma, pupil diameter measurements, and urine will be collected from 0-24 hours. A washout of at least 2 days will separate Arms 2 and 3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Kratom
2023
Completed Phase 1
~60
Oxycodone
2014
Completed Phase 4
~2210
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Herbal interactions, such as those involving kratom and oxycodone, primarily occur through the modulation of drug-metabolizing enzymes, particularly those in the cytochrome P450 family. Kratom, for instance, may inhibit or induce these enzymes, altering the breakdown and clearance of oxycodone in the body.
This can lead to either increased toxicity or reduced efficacy of the drug. Understanding these interactions is crucial for patients, as it helps in managing potential risks and optimizing therapeutic outcomes when using herbal products alongside conventional medications.
Find a Location
Who is running the clinical trial?
Washington State UniversityLead Sponsor
105 Previous Clinical Trials
57,412 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
849 Previous Clinical Trials
670,910 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My weight is either below 130 pounds or above 250 pounds.I have never used kratom or opioids.I have used kratom and opioids before without any bad reactions or addiction.I am either younger than 21 or older than 45 years old.I am willing to avoid dietary supplements, cannabis, THC/CBD products, and caffeinated drinks.I need strong painkillers soon or am already using them.My weight is between 130 and 250 pounds and my BMI is between 19 and 30.I am not taking any drugs or supplements that affect how oxycodone or kratom works in my body.I have a major or chronic illness.I am between 21 and 45 years old and in good health.I am on medications that affect how kratom or oxycodone works in my body.I have recently used cannabis, hemp, or products containing THC or CBD.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 3
- Group 2: Arm 2
- Group 3: Arm 4
- Group 4: Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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