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

NCT05846451 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-12-20

No results posted yet for this study

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

Conditions

  • Herbal Interaction

Interventions

DIETARY_SUPPLEMENT

Kratom

Kratom (Moon Kratom Yellow Indonesian, lot 51) is supplied as a dry leaf powder in clear plastic bags, each weighing 5 kg. Two grams of kratom dry leaf powder will be stirred into 240 mL of hot water to make a tea. The tea will be cooled to 50 degrees Celsius before administration. Participants will drink the tea within 15 minutes.

DRUG

Oxycodone

Immediate-release oral tablet, 10 mg

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Washington State University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-05-01
Completion
2025-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05846451 on ClinicalTrials.gov