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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04672382
Other study ID # N-20200084
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date December 31, 2022

Study information

Verified date January 2023
Source Aalborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to the effect of opioid (morphine) intradermal application on histaminergic and non-histaminergic itch. In particular, we would like to demonstrate that also peripheral administration of morphine may affect mast cell release of histamine.


Description:

Opioids (i.e. substances extracted from opium poppies, e.g. morphine) are used for treatment of both acute and chronic pain conditions as well as in surgical procedures. Opioids render effective pain relief, however, they may cause bothersome itch as a side effect. With this series of experiments, we wish to clarify how an injection with morphine in the skin layer called dermis (located right below the upper skin) will affect itch.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date December 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Morphine
During the 1st session, each of the middle forearms of the subject will be divided into two squared areas (4x4 cm) located 3 cm apart. Two areas will be treated with an intradermal injection of morphine (0.05 ml, 0.1 mg/ml), and two areas with an intradermal injection of isotonic saline.

Locations

Country Name City State
Denmark Silvia Lo Vecchio Aalborg Nordjylland

Sponsors (1)

Lead Sponsor Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measuring itch by computerized Visual Analog Scale Scoring We will ask the subjects to rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable". 10 minutes
Primary Measuring pain by computerized Visual Analog Scale Scoring We will ask the subjects to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable". 10 minutes
Primary Superficial blood perfusion measurement Superficial blood perfusion is measured by a Speckle contrast imager 15 minutes
Secondary While size While size will be assessed with a ruler 15 minutes
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