Assessment of Peripheral GABA Receptors for Local Pain Relief

NCT ID: NCT02928328

Last Updated: 2018-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-12-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

GABA oral solution

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Intramuscular GABA

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Pain modulation

Intervention Type: DRUG

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

Interventions

GABA oral solution

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

Intervention Type: DRUG

Intramuscular GABA

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

gamma aminobutyric acid; lidocaine; distilled water; capsaicin; gamma aminobutyric acid; lorazepam; buffered isotonic saline; gamma butyric acid; glutamate; lorazepam

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Brian E Cairns

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian E Cairns, PhD DrMed

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Locations

Aalborg University

Aalborg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Brian E Cairns, PhD, DrMed

Role: CONTACT

bec@hst.aau.dk

+45 99407521

Facility Contacts

Kelun Wang, DDS, PhD

Role: primary

kelun@hst.aau.dk

References

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.

Reference Type: RESULT

PMID: 29024230 (View on PubMed)

Other Identifiers

N-20160037

Identifier Type: -

Identifier Source: org_study_id