Assessment of Peripheral GABA Receptors for Local Pain Relief

January 8, 2018 updated by: Brian E Cairns, Aalborg University

Vurdering af Perifere GABAA-receptorer Med Henblik på Lokal Smertelindring

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.

Study Overview

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

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Brian E Cairns, PhD, DrMed
  • Phone Number: +45 99407521
  • Email: bec@hst.aau.dk

Study Locations

      • Aalborg, Denmark, 9220
        • Recruiting
        • Aalborg University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.
Oral mouth wash containing either GABA, lidocaine or distilled water will be used to decrease burning tongue pain produced by capsaicin
Other Names:
  • lidocaine
  • distilled water
  • capsaicin
  • gamma aminobutyric acid
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.
The effect of intramuscular injection of GABA or lorazepam will be compared with buffered isotonic saline
Other Names:
  • lorazepam
  • gamma aminobutyric acid
  • 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.
The effect of GABA alone or in combination with lorazepam on muscle pain produced by intramuscular injection of glutamate will be assessed.
Other Names:
  • lorazepam
  • gamma butyric acid
  • glutamate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity Rating
Time Frame: continuously for 95 minutes
visual analogue scale
continuously for 95 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Brian E Cairns, PhD DrMed, Aalborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

October 6, 2016

First Submitted That Met QC Criteria

October 7, 2016

First Posted (Estimate)

October 10, 2016

Study Record Updates

Last Update Posted (Actual)

January 10, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on GABA oral solution

Subscribe