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CompletedNCT04700007Updated Jan 27, 2022

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

An interventional study of Capsaicin and Diphenhydramine in Itch, sponsored by Aalborg University. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-27.

Sponsored by Aalborg University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Itch
03

In context

Lead sponsor

Aalborg University is the lead sponsor of 178 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Study group

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

Interventions

  • DrugCapsaicin

    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.

  • DrugDiphenhydramine

    Diphenhydramin cream 1% (Restamine®) will be applied on a 3x3 cm squared predetermined area on the volar forearm for 24 hours.

    Also known as: Antihistamine

  • DrugMorphine 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.

  • DrugIsotonic saline

    injections of isotonic saline (0.05 ml, 0.9%) as vehicle will be performed.

  • DrugHistamine

    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.

06

What researchers measure

Primary outcomes

  1. Measuring itch intensity 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".

    Time frame: For 10 minutes

  2. Measuring pain intensity 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".

    Time frame: For 10 minutes

  3. Superficial blood perfusion measurement

    Superficial blood perfusion is measured by a Speckle contrast imager

    Time frame: After 15 minutes

Secondary outcomes

  1. While size

    While size will be assessed using a ruler

    Time frame: After 15 minutes

07

Study locations

1 site
  • Mech-Sense, Medicinsk Gastroenterologisk ambulatorium, Medicineshus, Aalborn Universitethospitalet
    AAlborg, Nordjylland 9000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04700007
Lead sponsor
Aalborg University
Responsible party
Silvia Lo Vecchio (PhD, Assistant Professor, Aalborg University) — Principal investigator
First posted
Jan 7, 2021
Start date
Jan 18, 2021
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Jan 27, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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