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

Sponsor
Aalborg University (Other)
Overall Status
Completed
CT.gov ID
NCT04700007
Collaborator
(none)
26
Enrollment
1
Location
1
Arm
11.4
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effect of Intradermal Morphine Application on Histaminergic and Non-histaminergic Itch and Related TRPV1 and Antihistamine Treatments (2nd Sub-project)
Actual Study Start Date :
Jan 18, 2021
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study group

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.
Other Names:
  • Antihistamine

    • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Measuring itch intensity by computerized Visual Analog Scale Scoring [For 10 minutes]

      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".

    2. Measuring pain intensity by computerized Visual Analog Scale Scoring [For 10 minutes]

      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".

    3. Superficial blood perfusion measurement [After 15 minutes]

      Superficial blood perfusion is measured by a Speckle contrast imager

    Secondary Outcome Measures

    1. While size [After 15 minutes]

      While size will be assessed using a ruler

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mech-Sense, Medicinsk Gastroenterologisk ambulatorium, Medicineshus, Aalborn Universitethospitalet AAlborg Nordjylland Denmark 9000

    Sponsors and Collaborators

    • Aalborg University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Silvia Lo Vecchio, PhD, Assistant Professor, Aalborg University
    ClinicalTrials.gov Identifier:
    NCT04700007
    Other Study ID Numbers:
    • N-20200084 2nd sub-project
    First Posted:
    Jan 7, 2021
    Last Update Posted:
    Jan 27, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diphenhydramine
    Promethazine
    Morphine
    Capsaicin
    Histamine

    Study Results

    No Results Posted as of Jan 27, 2022