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Assessment of Peripheral GABA Receptors for Local Pain Relief

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ClinicalTrials.gov Identifier: NCT02928328
Recruitment Status : Recruiting
First Posted : October 10, 2016
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Brian E Cairns, Aalborg University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: GABA oral solution Drug: Intramuscular GABA Drug: Pain modulation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Vurdering af Perifere GABAA-receptorer Med Henblik på Lokal Smertelindring
Actual Study Start Date : October 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
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.
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
Other Names:
  • gamma aminobutyric acid
  • lidocaine
  • distilled water
  • capsaicin

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.
Drug: Intramuscular GABA
The effect of intramuscular injection of GABA or lorazepam will be compared with buffered isotonic saline
Other Names:
  • gamma aminobutyric acid
  • lorazepam
  • buffered isotonic saline

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.
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.
Other Names:
  • gamma butyric acid
  • glutamate
  • lorazepam




Primary Outcome Measures :
  1. Pain Intensity Rating [ Time Frame: continuously for 95 minutes ]
    visual analogue scale


Secondary Outcome Measures :
  1. Jaw Function Tests [ Time Frame: every 5 min for 50 minutes ]
    maximal jaw opening, maximal bite force

  2. Quantitative Sensory testing [ Time Frame: every 10 min for 90 min ]
    Pressure detection and pain threshold, thermal detection and pain threshold



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02928328


Contacts
Contact: Brian E Cairns, PhD, DrMed +45 99407521 bec@hst.aau.dk

Locations
Denmark
Aalborg University Recruiting
Aalborg, Denmark, 9220
Contact: Kelun Wang, DDS, PhD       kelun@hst.aau.dk   
Sponsors and Collaborators
Aalborg University
Investigators
Principal Investigator: Brian E Cairns, PhD DrMed Aalborg University

Publications of Results:
Responsible Party: Brian E Cairns, Professor, Aalborg University
ClinicalTrials.gov Identifier: NCT02928328     History of Changes
Other Study ID Numbers: N-20160037
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Brian E Cairns, Aalborg University:
craniofacial pain
masticatory muscle
burning mouth syndrome
temporomandibular disorders

Additional relevant MeSH terms:
Pharmaceutical Solutions
Lidocaine
Lorazepam
Capsaicin
gamma-Aminobutyric Acid
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Anticonvulsants
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents