What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Herbal treatments similar to kratom, such as ginseng and cannabis, have been studied for their interactions with conventional medications. Common side effects of these herbal treatments include gastrointestinal issues (e.g., nausea, vomiting), psychological effects (e.g., euphoria, hallucinations), and potential for drug interactions that may alter the metabolism of other medications. For instance, ginseng has been noted to interact with warfarin, potentially affecting its efficacy. Additionally, cannabinoids have shown inconsistent results in managing symptoms and may cause minor adverse effects like dizziness and dry mouth.

What prior FDA approvals exist?

The FDA has not specifically approved any treatments for managing herbal interactions with pharmaceuticals like kratom's potential modulation of oxycodone metabolism. However, the FDA does regulate and provide guidelines for the safe use of herbal supplements and their interactions with prescription medications. It is crucial for patients to consult healthcare providers before combining herbal products with prescription drugs to avoid adverse interactions.

What other types of research exist?

Promising, novel alternatives to Kratom for patients considering treatment in 2024 include: 1) Saw Palmetto, which has been studied for its effects on cytochrome P450 enzymes, potentially affecting drug metabolism. 2) Green Tea Polyphenols, which have shown potential in modulating drug effects and have been studied in various cancer treatments. 3) Hypericin from St. John's Wort, known for its interaction with drug metabolism enzymes and potential analgesic effects. Patients should consult with their healthcare provider to evaluate the suitability and safety of these alternatives.

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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

No Placebo-Only Group

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-24 hours for reporting.

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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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.