Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06089980
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2023-10-12
Brief Title:
Direct Observation Study of Kratom Product Effects Among Regular Consumers
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Observing the Acute Effects Following a Single Oral Dose of Kratom and Effects Following Kratom Cessation Among Adults Who Use Regularly
Status:
RECRUITING
Status Verified Date:
2024-04
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 observational clinical study is to is to learn more about how commercial kratom products affect healthy adults who consume them regularly The main questions it aims to answer are
1 What are the acute physiological subjective and cognitive effects of kratom following participant self-administration of a single oral dose of the participants usual kratom product at the participants typical dose
2 What are the physiological subjective and cognitive effects associated with kratom product discontinuation among adults who use regularly
3 What are the pharmacokinetics of kratom products consumed by adults who use regularly On the first study day Under direct observation participants will self-administer a single oral dose of the participants own commercial kratom product that that is regularly taken and will consume it at the participants self-selected typical doseserving Following this serial blood draws and urine collection will occur along with administration of validated questionnaires tests and continual monitoring After this first study day participants will no longer be permitted to use any of the participants kratom product during the study On study nightsdays 2-3 participants will reside a clinical research unit and be observed and evaluated for kratom withdrawal syndrome
1 What are the acute physiological subjective and cognitive effects of kratom following participant self-administration of a single oral dose of the participants usual kratom product at the participants typical dose
2 What are the physiological subjective and cognitive effects associated with kratom product discontinuation among adults who use regularly
3 What are the pharmacokinetics of kratom products consumed by adults who use regularly On the first study day Under direct observation participants will self-administer a single oral dose of the participants own commercial kratom product that that is regularly taken and will consume it at the participants self-selected typical doseserving Following this serial blood draws and urine collection will occur along with administration of validated questionnaires tests and continual monitoring After this first study day participants will no longer be permitted to use any of the participants kratom product during the study On study nightsdays 2-3 participants will reside a clinical research unit and be observed and evaluated for kratom withdrawal syndrome
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None