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

A

Aalborg University

Status

Completed

Conditions

Itch

Treatments

Drug: Isotonic saline
Drug: Diphenhydramine
Drug: Morphine Chloride
Drug: Histamine
Drug: Capsaicin

Study type

Interventional

Funder types

Other

Identifiers

NCT04700007
N-20200084 2nd sub-project

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy men and women
  • 18-60 years
  • Speak and understand English

Exclusion criteria

  • Participants with any clinically significant abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
  • Pregnancy or lactation
  • Drug addiction defined as any use of cannabis, opioids or other addictive drugs
  • Lack of ability to cooperate
  • Current use of medications that may affect the trial such as antihistamines, antipsychotics and pain killers as well as systemic or topical steroids.
  • Participants with known allergy/discomfort to the opioid morphine and antihistamine.
  • Skin diseases
  • Moles, scars or tattoos in the area to be treated or tested.
  • Consumption of alcohol or painkillers 24 hours before the study days and between these
  • Acute or chronic pain
  • Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

Study group
Experimental group
Treatment:
Drug: Capsaicin
Drug: Isotonic saline
Drug: Morphine Chloride
Drug: Diphenhydramine
Drug: Histamine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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