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Assessment of Peripheral GABA Receptors for Local Pain Relief

Vurdering af Perifere GABAA-receptorer Med Henblik på Lokal Smertelindring

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02928328
Enrollment
90
Registered
2016-10-10
Start date
2016-10-31
Completion date
2019-12-31
Last updated
2018-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

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

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.

Interventions

DRUGGABA oral solution

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

DRUGIntramuscular GABA

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

DRUGPain modulation

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

Sponsors

Aalborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Intensity Ratingcontinuously for 95 minutesvisual analogue scale

Secondary

MeasureTime frameDescription
Jaw Function Testsevery 5 min for 50 minutesmaximal jaw opening, maximal bite force
Quantitative Sensory testingevery 10 min for 90 minPressure detection and pain threshold, thermal detection and pain threshold

Countries

Denmark

Contacts

Primary ContactBrian E Cairns, PhD, DrMed
bec@hst.aau.dk+45 99407521

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026