Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-29 @ 5:01 PM
Study NCT ID:
NCT05846451
Status:
RECRUITING
Last Update Posted:
2024-12-20
First Post:
2023-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating a Potential Pharmacokinetic Kratom-oxycodone Interaction Concurrent With Clinical Endpoints
Sponsor:
Washington State University
Organization:
Study Overview
Official Title:
Evaluating a Potential Pharmacokinetic Kratom-oxycodone Interaction Concurrent With Clinical Endpoints
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
The primary objective of this study is to evaluate the potential for kratom to precipitate a pharmacokinetic interaction with the common opioid and dual cytochrome P450 (CYP) 3A/CYP2D6 substrate oxycodone. A secondary objective is to evaluate a potential pharmacodynamic interaction by measuring pupil diameter, the most sensitive measure of central nervous system opioid effects. To evaluate these objectives, participants will complete four arms, during which they will be administered the following:
* Arm 1: a single low dose of kratom (by mouth, as a tea)
* Arm 2: a single low dose of immediate-release oxycodone (by mouth, as a tablet)
* Arm 3: a single low dose of kratom tea and a single low dose of oxycodone
* Arm 4: daily at-home self-administration of kratom tea for four days, followed immediately by a single low dose of kratom tea and a single low dose of oxycodone in the research setting
* Arm 1: a single low dose of kratom (by mouth, as a tea)
* Arm 2: a single low dose of immediate-release oxycodone (by mouth, as a tablet)
* Arm 3: a single low dose of kratom tea and a single low dose of oxycodone
* Arm 4: daily at-home self-administration of kratom tea for four days, followed immediately by a single low dose of kratom tea and a single low dose of oxycodone in the research setting
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U54AT008909 | NIH | None | https://reporter.nih.gov/quic… | View |