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| ID | Type | Description | Link |
|---|---|---|---|
| 5P01NS119159 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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This study aims to answer the question: Does oxytocin increase the pain threshold on thermal heat pain in the presence of vibration on an area of skin exposed to a mild sunburn?
The goal of this clinical trial is to test whether intravenous oxytocin increases the analgesic effect of vibration on heat pain threshold of skin that has been exposed to Ultraviolet-B (UV-B) burn (mild sunburn). Researchers will compare oxytocin (a hormone that naturally occurs in the body) to a placebo (a look-alike substance that contains no drug) to see if oxytocin works to increase the pain threshold (the lowest intensity at which one begins to perceive or sense a stimulus as being painful).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxytocin | Experimental | Two 30 minute infusions of oxytocin, 10 International Units (IU) separated by 30 minutes. To avoid potential unmasking by facial flushing which can occur at the beginning of high rates of oxytocin administration, the first infusion will consist of two steps beginning with a rate of 0.125 IU oxytocin per minute for 5 minutes, then increased to 0.375 IU oxytocin for 25 minutes. The second infusion will be a constant rate of 0.333 IU oxytocin per minute for 30 minutes. |
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| placebo | Placebo Comparator | Two 30 minute infusions of placebo separated by 30 minutes. The first infusion will consist of two steps, using an equivalent volume of placebo fluid infusion as in the oxytocin arm. This will consist of a slower rate in the first 5 minutes and more rapid rate for the last 25 min. The second placebo solution infusion will be a constant rate and volume equivalent to that used in the oxytocin arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxytocin | Drug | Oxytocin 10 IU will be administered over 30 minutes by intravenous infusion and repeated 30 minutes after the end of the first infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference between heat pain threshold | Difference between heat pain threshold at 24 hours after Ultraviolet-B (UV-B) exposure at 3x minimum erythematous dose. The difference between the average threshold for stimuli #5-8 and the average threshold for stimuli #13-17 at baseline and 2 hours after the beginning of the oxytocin or placebo infusion will be used. The values are measured in degrees Celsius. A lower temperature indicates more sensitivity to heat pain. | 24 hours after UV-B exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between heat pain threshold | Difference between heat pain threshold at 24 hours after UV-B exposure at 3x minimum erythematous dose. The difference between the average threshold for stimuli #5-8 and the average threshold for stimuli #13-17 at baseline and 2 days after the beginning of the oxytocin or placebo infusion will be used. The values are measured in degrees Celsius. A lower temperature indicates more sensitivity to heat pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James C Eisenach, M.D. | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 8, 2025 | Dec 10, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013471 | Sunburn |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010787 | Photosensitivity Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002056 | Burns |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| placebo | Drug | A placebo will be administered over 30 minutes by intravenous infusion and repeated 30 minutes after the end of the first infusion. |
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| Two days after UV-B exposure |
| Touch and pain threshold to von Frey filament application | Using an electronic von Frey instrument, threshold for touch and a prickly pain sensation will be determined at the site of UV-B exposure at 3x minimum erythematous dose and in normal skin to estimate the threshold for touch and prickly pain sensation. The measure will be recorded in grams. A lower pressure indicates more sensitivity to touch and pain. | 24 hours after UV-B exposure |
| Touch and pain threshold to von Frey filament application | Using an electronic von Frey instrument, threshold for touch and a prickly pain sensation will be determined at the site of UV-B exposure at 3x minimum erythematous dose and in normal skin to estimate the threshold for touch and prickly pain sensation. The measure will be recorded in grams. A lower pressure indicates more sensitivity to touch and pain. | Two days after UV-B exposure |
| D014947 |
| Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |