Viewing Study NCT06245564



Ignite Creation Date: 2024-05-06 @ 8:04 PM
Last Modification Date: 2024-10-26 @ 3:20 PM
Study NCT ID: NCT06245564
Status: RECRUITING
Last Update Posted: 2024-07-11
First Post: 2024-01-25

Brief Title: Effect of Ketamine Amitriptyline and Their Combination on Itch
Sponsor: Aalborg University
Organization: Aalborg University

Study Overview

Official Title: Effect of Ketamine Amitriptyline and Their Combination on Histaminergic and Non-histaminergic Itch
Status: RECRUITING
Status Verified Date: 2024-10
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: Chronic itch affects approximately a fifth of the global population and is associated with substantial negative consequences for the affected individuals Furthermore there is a lack of efficient treat-ment options for chronic itch Topical ketamine cream has been used successfully to relieve various forms of pain and we hypothesize that topical ketamine relieves itch through a mechanism of action comparable to that in pain relief

The aim of this project is to evaluate the effects of ketamine both alone and in combination with amitriptyline on histaminergic and non-histaminergic itch induced by histamine and cowhage respectively
Detailed Description: The main action of ketamine 2-2-chlorophenyl-2-methylamino-cyclohexanone is to antagonize the glutamate N-methyl-D-aspartate NMDA receptors In the clinical setting topical ketamine cream has been used successfully to relieve various pathogenic forms of pain In addition to its pain-relieving effects the cream was also reported to have itch-relieving properties in a very limited study However its efficacy on itch has not been established and the mechanism of action remains uncertain Ketamine cream is used not only by itself but also in conjunction with other analgesics One of these is amitriptyline which may enhance the analgesic effects of ketamine The aim of this human experimental study is to use the well-characterized anesthetic Ketamine both alone and in combination with amitriptyline as a tool to modulate different histaminergic and non-histaminergic itch modalities evoked by histamine and cowhage

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