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

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ClinicalTrials.gov Identifier: NCT04700007
Recruitment Status : Completed
First Posted : January 7, 2021
Last Update Posted : January 27, 2022
Sponsor:
Information provided by (Responsible Party):
Silvia Lo Vecchio, Aalborg University

Study Description
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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
Itch Drug: Capsaicin Drug: Diphenhydramine Drug: Morphine Chloride Drug: Isotonic saline Drug: Histamine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : January 18, 2021
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

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Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. Measuring itch intensity by computerized Visual Analog Scale Scoring [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: After 15 minutes ]
    Superficial blood perfusion is measured by a Speckle contrast imager


Secondary Outcome Measures :
  1. While size [ Time Frame: After 15 minutes ]
    While size will be assessed using a ruler


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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700007


Locations
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Denmark
Mech-Sense, Medicinsk Gastroenterologisk ambulatorium, Medicineshus, Aalborn Universitethospitalet
AAlborg, Nordjylland, Denmark, 9000
Sponsors and Collaborators
Aalborg University
More Information
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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: January 7, 2021    Key Record Dates
Last Update Posted: January 27, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diphenhydramine
Promethazine
Morphine
Capsaicin
Histamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antipruritics
Dermatologic Agents
 Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Anesthetics, Local
Anesthetics
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Histamine Agonists