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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

Tracking Information
First Submitted Date  ICMJE October 6, 2016
First Posted Date  ICMJE October 10, 2016
Last Update Posted Date January 10, 2018
Actual Study Start Date  ICMJE October 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2016)
Pain Intensity Rating [ Time Frame: continuously for 95 minutes ]
visual analogue scale
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2016)
Pain Intensity Rating [ Time Frame: 90 minutes ]
visual analogue scale
Change History Complete list of historical versions of study NCT02928328 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2016)
  • Jaw Function Tests [ Time Frame: 90 min ]
    maximum bite force
  • Jaw Function Tests [ Time Frame: 90 min ]
    maximal jaw opening
  • Quantitative Sensory testing [ Time Frame: 90 min ]
    Pressure pain threshold
  • Quantitative Sensory Testing [ Time Frame: 90 min ]
    thermal detection threshold
  • Quantitative Sensory Testing [ Time Frame: 90 min ]
    thermal pain threshold
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Peripheral GABA Receptors for Local Pain Relief
Official Title  ICMJE Vurdering af Perifere GABAA-receptorer Med Henblik på Lokal Smertelindring
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Pain
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Drug: Pain modulation
Publications * Zhang Y, Wang K, Arendt-Nielsen L, Cairns BE. γ-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2016)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Brian E Cairns, PhD, DrMed +45 99407521 bec@hst.aau.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02928328
Other Study ID Numbers  ICMJE N-20160037
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brian E Cairns, Aalborg University
Study Sponsor  ICMJE Aalborg University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brian E Cairns, PhD DrMed Aalborg University
PRS Account Aalborg University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP