Assessment of Peripheral GABA Receptors for Local Pain Relief

Pain Clinical Trial

Official title:

Vurdering af Perifere GABAA-receptorer Med Henblik på Lokal Smertelindring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02928328
• Other study ID #: N-20160037
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2016
• Last updated: January 8, 2018
• Start date: October 2016
• Est. completion date: December 2019

Study information

• Verified date: January 2018
• Source: Aalborg University
• Contact: Brian E Cairns, PhD, DrMed
• Phone: +45 99407521
• Email: bec[@]hst.aau.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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
• Intramuscular GABA
The effect of intramuscular injection of GABA or lorazepam will be compared with buffered isotonic saline
• Pain modulation
The effect of GABA alone or in combination with lorazepam on muscle pain produced by intramuscular injection of glutamate will be assessed.

Locations

Country	Name	City	State
Denmark	Aalborg University	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Zhang Y, Wang K, Arendt-Nielsen L, Cairns BE. ?-Aminobutyric acid (GABA) oral rinse reduces capsaicin-induced burning mouth pain sensation: An experimental quantitative sensory testing study in healthy subjects. Eur J Pain. 2017 Oct 11. doi: 10.1002/ejp.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity Rating	visual analogue scale	continuously for 95 minutes
Secondary	Jaw Function Tests	maximal jaw opening, maximal bite force	every 5 min for 50 minutes
Secondary	Quantitative Sensory testing	Pressure detection and pain threshold, thermal detection and pain threshold	every 10 min for 90 min