NCT04700007

Evaluation of Peripheral Itch Mechanisms Following Injection of Morphine (Second Sub-Project)

Effect of Intradermal Morphine Application on Histaminergic and Non-histaminergic Itch and Related TRPV1 and Antihistamine Treatments (2nd Sub-project)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Aalborg University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The aim of our 2nd sub-project is to clarify if the capsaicin receptor TRPV1 is implicated in the mechanism of morphine-induced mast cell degranulation. Moreover, we also aim to clarify if the mechanism of opioid-induced itch relay on the histaminergic pathway by using the antihistamine (diphenhydramine) to suppress the release of histamine from peripheral mast cells.

Conditions

• Itch

Interventions

Type	Name	Description
DRUG	Capsaicin	A capsaicin patch will be applied on a 3x3 cm squared area on the volar forearm. The patch will be left in place for 24h after which it will be removed.
DRUG	Diphenhydramine	Diphenhydramin cream 1% (Restamine®) will be applied on a 3x3 cm squared predetermined area on the volar forearm for 24 hours.
DRUG	Morphine Chloride	Morphine solution (0.1mg/ml, Morphine Hydrochloride) 50 μl will be applied intradermally to the center of a predetermined area on the volar forearm by a 1 ml syringe.
DRUG	Isotonic saline	injections of isotonic saline (0.05 ml, 0.9%) as vehicle will be performed.
DRUG	Histamine	A small drop of histamine dihydrochloride (1%, in saline) will be applied to a previously determined area on the volar forearm followed by a prick through the drop.

Timeline

• Start date: 2021-01-18
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-01-07
• Last updated: 2022-01-27

Locations

1 site across 1 country: Denmark