Assessment of Peripheral GABA Receptors for Local Pain Relief

Aalborg University

Status: Unknown

Conditions: Pain

Treatments: Drug: GABA oral solution; Drug: Pain modulation; Drug: Intramuscular GABA

Study type: Interventional

Funder types: Other

Identifiers

NCT02928328

N-20160037

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

90 participants in 3 patient groups

GABA oral solution

Experimental group

Description:

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.

Treatment:

Drug: GABA oral solution

Intramuscular GABA

Experimental group

Description:

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.

Treatment:

Drug: Intramuscular GABA

Pain modulation

Experimental group

Description:

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.

Treatment:

Drug: Pain modulation