Effect of Ketamine, Amitriptyline and Their Combination on Itch

Last updated: January 28, 2025
Sponsor: Aalborg University
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Ketamine 0.5%

Amitriptyline

ketamine + amitriptyline

Clinical Study ID

NCT06245564
N-20230046
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Chronic itch affects approximately a fifth of the global population and is associated with substantial negative consequences for the affected individuals. Furthermore, there is a lack of efficient treat-ment options for chronic itch. Topical ketamine cream has been used successfully to relieve various forms of pain, and we hypothesize that topical ketamine relieves itch through a mechanism of action comparable to that in pain relief.

The aim of this project is to evaluate the effects of ketamine both alone and in combination with amitriptyline on histaminergic and non-histaminergic itch induced by histamine and cowhage, respectively.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy men and women

  • 18-60 years

  • Speak and understand English

Exclusion

Exclusion Criteria:

  • Pregnancy or lactation

  • Drug addiction defined as any use of cannabis, opioids, or other drugs

  • Previous or current history of neurological, dermatological, immunological,musculoskeletal, cardiac disorder or mental illnesses (psychiatric diagnosis) thatmay affect the results (e.g., neuropathy, muscular pain in the upper extremities,anxiety, depression, schizophrenia etc.)

  • Moles, wounds, scars, or tattoos in the area to be treated or tested

  • Current use of medications that may affect the trial such as antihistamines and painkillers.

  • Participants had known allergy/discomfort to ketamine or amitriptyline

  • Skin diseases

  • Consumption of alcohol or painkillers 24 hours before the study days and betweenthese

  • Acute or chronic pain and itch

  • Participation in other trials within 1 week of study entry (4 weeks in the case ofpharmaceutical studies)

  • Lack of ability to cooperate

Study Design

Total Participants: 30
Treatment Group(s): 6
Primary Treatment: Ketamine 0.5%
Phase:
Study Start date:
August 20, 2024
Estimated Completion Date:
December 31, 2024

Study Description

The main action of ketamine, 2-(2-chlorophenyl)-2-(methylamino)-cyclohexanone, is to antagonize the glutamate N-methyl-D-aspartate (NMDA) receptors. In the clinical setting, topical ketamine cream has been used successfully to relieve various pathogenic forms of pain. In addition to its pain-relieving effects, the cream was also reported to have itch-relieving properties in a very limited study. However, its efficacy on itch has not been established, and the mechanism of action remains uncertain. Ketamine cream is used not only by itself, but also in conjunction with other analgesics. One of these is amitriptyline, which may enhance the analgesic effects of ketamine. The aim of this human experimental study is to use the well-characterized anesthetic Ketamine, both alone and in combination with amitriptyline, as a tool to modulate different histaminergic and non-histaminergic itch modalities evoked by histamine and cowhage.

Connect with a study center

  • Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University

    Gistrup, Aalborg 9260
    Denmark

    Site Not Available

  • Silvia Lo Vecchio

    Aalborg, 9260
    Denmark

    Site Not Available

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