Assessment of Peripheral GABA Receptors for Local Pain Relief

NCT02928328 | Unknown DMC

• 1 other identifier: N-20160037
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

craniofacial pain; masticatory muscle; burning mouth syndrome; temporomandibular disorders

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Rating

  visual analogue scale

  continuously for 95 minutes

Secondary Outcomes (2)

• Jaw Function Tests

  every 5 min for 50 minutes

• Quantitative Sensory testing

  every 10 min for 90 min

Study Arms (3)

GABA oral solution

EXPERIMENTAL

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

Intramuscular GABA

EXPERIMENTAL

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

Pain modulation

EXPERIMENTAL

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

GABA oral solution DRUG

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

GABA oral solution

Intramuscular GABA DRUG

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

Intramuscular GABA

Pain modulation DRUG

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

Pain modulation

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Aalborg University

Aalborg, 9220, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 29024230 RESULT

MeSH Terms

Conditions

Pain; Facial Pain; Burning Mouth Syndrome; Temporomandibular Joint Disorders

Interventions

gamma-Aminobutyric Acid; Lidocaine; Capsaicin; Lorazepam; Glutamic Acid

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases

Intervention Hierarchy (Ancestors)

Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Polyunsaturated Alkamides; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids, Dicarboxylic; Excitatory Amino Acids

Study Officials

• Brian E Cairns, PhD DrMed

  Aalborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian E Cairns, PhD, DrMed

CONTACT

+45 99407521; bec@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 10, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: January 10, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)