CClinicalTrials.gg
Status unknownNCT02928328Updated Jan 10, 2018

Assessment of Peripheral GABA Receptors for Local Pain Relief

An interventional study of GABA oral solution and Intramuscular GABA in Pain, sponsored by Aalborg University. Status unknown at 1 site in Denmark. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-10.

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

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain

Keywords

  • craniofacial pain
  • masticatory muscle
  • burning mouth syndrome
  • temporomandibular disorders
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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
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Aged 20-40 years
  • Free from ongoing or chronic pain
  • Adequate conversational English

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugGABA oral solution

    Oral mouth wash containing either GABA, lidocaine or distilled water will be used to decrease burning tongue pain produced by capsaicin

    Also known as: gamma aminobutyric acid, lidocaine, distilled water, capsaicin

  • DrugIntramuscular GABA

    The effect of intramuscular injection of GABA or lorazepam will be compared with buffered isotonic saline

    Also known as: gamma aminobutyric acid, lorazepam, buffered isotonic saline

  • DrugPain modulation

    The effect of GABA alone or in combination with lorazepam on muscle pain produced by intramuscular injection of glutamate will be assessed.

    Also known as: gamma butyric acid, glutamate, lorazepam

06

What researchers measure

Primary outcomes

  1. Pain Intensity Rating

    visual analogue scale

    Time frame: continuously for 95 minutes

Secondary outcomes

  1. Jaw Function Tests

    maximal jaw opening, maximal bite force

    Time frame: every 5 min for 50 minutes

  2. Quantitative Sensory testing

    Pressure detection and pain threshold, thermal detection and pain threshold

    Time frame: every 10 min for 90 min

07

Study locations

1 of 1 sites recruiting
  • Aalborg University
    Aalborg, 9220, Denmark
    Recruiting
08

References and documents

Publications

  • 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. PubMed 29024230 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02928328
Lead sponsor
Aalborg University
Responsible party
Brian E Cairns (Professor, Aalborg University) — Principal investigator
First posted
Oct 10, 2016
Start date
Oct 2016
Primary completion
Dec 2018 (estimated)
Completion
Dec 2019 (estimated)
Last update
Jan 10, 2018

Study contacts

Brian E Cairns, PhD, DrMed
Contact
bec@hst.aau.dk
+45 99407521
Brian E Cairns, PhD DrMed
principal investigator · Aalborg University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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