Evaluation of Peripheral Itch Mechanisms Following Injection of Morphine

NCT ID: NCT04672382

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-12-31

Brief 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.

Detailed 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.

Conditions

Morphine; Histamine; Cowhage; Isotonic Saline

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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), while two areas will be treated with injections of isotonic saline (0.05 ml, 0.9%) as vehicle. Fifteen minutes after the injections, the measurement of FLPI and wheal size will be conducted in one morphine and one saline treated area.

This measurement will be followed by application of histamine and cowhage in the four areas (two pre-treated with morphine and two pre-treated with vehicle)

Group Type: EXPERIMENTAL

Morphine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Silvia Lo Vecchio

PhD, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Silvia Lo Vecchio

Aalborg, North Denmark, Denmark

Countries

Denmark

Other Identifiers

N-20200084

Identifier Type: -

Identifier Source: org_study_id