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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
Study Summary
This trial studies if kratom affects how the body processes the opioid drug oxycodone to see if it changes its effects.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oxycodone area under the concentration vs. time curve (AUC) ratio (presence to absence of kratom)
Secondary outcome measures
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
Find a Location
Who is running the clinical trial?
Washington State UniversityLead Sponsor
101 Previous Clinical Trials
56,698 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
833 Previous Clinical Trials
669,437 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the trial recruiting participants who are older than 30 years?
"This medical experiment is open to volunteers aged between 21 and 45."
Answered by AI
Are there opportunities to enroll in this experiment currently?
"According to the clinicaltrials.gov information, no new candidates are being sought for this study at present; it was first advertised on October 1st 2023 and last updated on April 26th 2023. However, there are three other trials actively searching for participants."
Answered by AI
Who qualifies as an eligible participant of this research project?
"In order to be chosen for the trial, individuals must have had prior experience with herbal medications and fall between 21 and 45 years old. This clinical study is currently looking to bring in around 16 patients."
Answered by AI
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