Assessment of Peripheral GABA Receptors for Local Pain Relief

Overview

The effect of peripheral GABAA receptor activation on pain and sensitivity in healthy human subjects has never been investigated. However, as earlier studies suggest that activation of peripheral GABAA receptors is anti-nociceptive in rats, it is important to determine if these findings can be translated into human subjects to determine if peripheral GABAA receptors are a viable target for future analgesic drug development.

Full Title of Study: “Vurdering af Perifere GABAA-receptorer Med Henblik på Lokal Smertelindring”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2018

Detailed Description

Subproject I This study will test if oral administration of GABA containing solutions will reduce the pain and sensitivity induced by application of capsaicin to the tongue of healthy human subjects. Thirty, pain-free men (n=15) and women (n=15) for the oral cavity study. Subproject II This study will test the hypothesis that intramuscular injection of GABA alone will not be painful, but will reduce muscle pain sensitivity in healthy human subjects. Thirty, pain-free men (n=15) and women (n=15) will be recruited for the intramuscular GABA injection studies Subproject III This study will test the hypothesis that intramuscular injection of GABA with glutamate will decrease the intensity of glutamate-evoked muscle pain in healthy human subjects. Thirty, pain-free men (n=15) and women (n=15) will be recruited for the intramuscular glutamate and GABA injection studies.

Interventions

  • Drug: GABA oral solution
    • Oral mouth wash containing either GABA, lidocaine or distilled water will be used to decrease burning tongue pain produced by capsaicin
  • Drug: Intramuscular GABA
    • The effect of intramuscular injection of GABA or lorazepam will be compared with buffered isotonic saline
  • Drug: Pain modulation
    • The effect of GABA alone or in combination with lorazepam on muscle pain produced by intramuscular injection of glutamate will be assessed.

Arms, Groups and Cohorts

  • Experimental: GABA oral solution
    • This study will test if oral administration of GABA containing solutions will reduce the pain and sensitivity induced by application of capsaicin to the tongue of healthy human subjects.
  • Experimental: Intramuscular GABA
    • This study will test the hypothesis that intramuscular injection of GABA alone will not be painful, but will reduce muscle pain sensitivity in healthy human subjects.
  • Experimental: Pain modulation
    • This study will test the hypothesis that intramuscular injection of GABA with glutamate will decrease the intensity of glutamate-evoked muscle pain in healthy human subjects.

Clinical Trial Outcome Measures

Primary Measures

  • Pain Intensity Rating
    • Time Frame: continuously for 95 minutes
    • visual analogue scale

Secondary Measures

  • Jaw Function Tests
    • Time Frame: every 5 min for 50 minutes
    • maximal jaw opening, maximal bite force
  • Quantitative Sensory testing
    • Time Frame: every 10 min for 90 min
    • Pressure detection and pain threshold, thermal detection and pain threshold

Participating in This Clinical Trial

Inclusion Criteria

  • Aged 20-40 years – Free from ongoing or chronic pain – Adequate conversational English Exclusion Criteria:

  • Pregnancy or intent to become pregnant, breast feeding – Signs or symptoms of any serious systemic diseases – Current malignancies – High blood pressure – Requirement for chronic administration of psychiatric, analgesic or other medications that might influence their response to pain – Frequent recreational drug or alcohol use – Previous neurologic, musculoskeletal or mental illnesses – Lack of ability to cooperate

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Aalborg University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Brian E Cairns, Professor – Aalborg University
  • Overall Official(s)
    • Brian E Cairns, PhD DrMed, Principal Investigator, Aalborg University
  • Overall Contact(s)
    • Brian E Cairns, PhD, DrMed, +45 99407521, bec@hst.aau.dk

Citations Reporting on Results

Zhang Y, Wang K, Arendt-Nielsen L, Cairns BE. gamma-Aminobutyric acid (GABA) oral rinse reduces capsaicin-induced burning mouth pain sensation: An experimental quantitative sensory testing study in healthy subjects. Eur J Pain. 2018 Feb;22(2):393-401. doi: 10.1002/ejp.1128. Epub 2017 Oct 11.

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