Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640569
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Preliminary Characterization of Commercial Kratom Extract Products
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Preliminary Characterization of Commercial Kratom Extract Products
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To understand the acute subjective physiological and cognitive effects of commercial kratom extract products among US adults who consume these products regularly and to understand how these products are metabolized by the human body
Detailed Description:
Kratom products made from the botanical Mitragyna speciosa have proliferated in the United States since 2006 and now include a variety of brands and formulations Kratom whole-leaf products and kratom leaf-derived extract products are the two major types of products within the marketplace To date most studies have examined kratom whole-leaf products both in terms of self-report from consumers and in terms of two US-based small lab-based pharmacokineticpharmacodynamic PKPD studies In order to follow-up on the investigators prior work examining the acute effects of kratom in adults age 21 or older who regularly use whole-leaf kratom products the investigators propose a pilot study N16 that purposefully samples US adults who use popular kratom extract products sold legally in most of US including the state of Maryland Despite the widespread use of kratom extract products particularly among the best-selling brands the investigators have no independently collected and published data derived from human laboratory studies on the PKPD associated with these products The investigators will conduct a within-person single-dose pilot study wherein 16 adult consumers of kratom extract products will self-administer a single oral dose of the participants kratom extract As this is an exploratory pilot study the investigators are not making a priori hypothesis Rather this is a proof-of-concept pilot study needed to first measure the basic PK and PD physiological subjective cognitive responses to extract product servings taken by adults who consumed the extracts regularly There is immediate public health need to better understand kratom extract consumer experiences given that these products are unregulated but widely used Such data have ecological validity and can inform next steps for funding and research
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None