Assessment of Peripheral GABA Receptors for Local Pain Relief
Keywords
Abstract
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.
Dates
| Last Verified: | 12/31/2017 |
| First Submitted: | 10/05/2016 |
| Estimated Enrollment Submitted: | 10/06/2016 |
| First Posted: | 10/09/2016 |
| Last Update Submitted: | 01/07/2018 |
| Last Update Posted: | 01/09/2018 |
| Actual Study Start Date: | 09/30/2016 |
| Estimated Primary Completion Date: | 11/30/2018 |
| Estimated Study Completion Date: | 11/30/2019 |
Condition or disease
Intervention/treatment
Drug: GABA oral solution
Drug: Intramuscular GABA
Drug: Pain modulation
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: 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. | 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 |
| Experimental: 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. | Drug: Intramuscular GABA The effect of intramuscular injection of GABA or lorazepam will be compared with buffered isotonic saline |
| Experimental: 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. | 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. |
Eligibility Criteria
| Ages Eligible for Study | 20 Years To 20 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Pain Intensity Rating [continuously for 95 minutes]
Secondary Outcome Measures
1. Jaw Function Tests [every 5 min for 50 minutes]
2. Quantitative Sensory testing [every 10 min for 90 min]
