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This study proposes to evaluate the effects that a dose of oxytocin given by intramuscular (IM) injection (into the muscle) will have on an area of skin that has been exposed to ultraviolet (UV) light. The area of skin exposed to UV light will have a mild sun burn feeling.
Sensory testing will be performed on the area of UV burn. The area will be evaluated for sensitivity in 3 methods: touch, vibratory
This protocol aims to provide an estimate of effect size of intramuscular oxytocin on a test of Aβ and of Aδ fiber sensitivity in injured skin following ultraviolet B (UVB) burned skin.
For the primary goal - to examine the effects of oxytocin peripheral nerves after tissue injury - the investigators chose the controlled ultraviolet sunburn model.
The investigators propose a randomized, blinded, cross over design with treatment with oxytocin one day and placebo on another. Following baseline measures on each of the two study days, participants will receive an intramuscular injection of oxytocin (Pitocin®) in its indicated dose of 10 IU (17 μg) or an equivalent volume of saline.
In order to determine the highest frequency that Aβ nerve fibers can respond to, the investigators will use a device that produces an oscillatory / vibratory stimulus which can be used on the hand.
Pain threshold to punctate stimulation within the area of irradiation will be determined using calibrated von Frey filaments and an up-down sequential method which efficiently estimates median thresholds.
Thermal heat testing will also be performed by the surface of the skin of the forearm or leg is heated to 45°C using a computer controlled thermode for a period of 5 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin first, then saline placebo | Other | Intramuscular injection of oxytocin (Pitocin®), 10 IU on the first study day and of 1 ml saline placebo on the second study day |
|
| Saline placebo first, then oxytocin | Placebo Comparator | Intramuscular injection of 1 ml saline placebo on the second study day and of oxytocin (Pitocin®), 10 IU on the second study day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | 10 IU oxytocin (Pitocin) for intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vibration Frequency Detection Threshold (When Vibration is First Felt) After IM Injection | Vibration frequency detection threshold in the burned area after IM Oxytocin or placebo injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented. | From 5 minutes to 120 minutes |
| Change in Pain Threshold (the Point Where Pain is First Perceived) to a Punctate Mechanical Stimulus After IM Injection. | Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin or Placebo injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented. | From 5 minutes to 120 minutes |
| Change in Hypersensitivity to Von Frey Filament (225 milliNewton) After IM Injection. | Hypersensitivity in the burned area after IM Oxytocin or placebo injection will be obtained by using a von Frey filament (small filament that is similar to a paint brush bristle). The skin will be touched with the filament and the participant will state when sensitivity is perceived and the area marked and measured in centimeters squared. | From 5 minutes to 65 minutes |
| Change in Vibration Frequency Detection of Fixed Frequency (When Vibration is First Felt) After IM Injection | Vibration frequency detection of a fixed frequency (256 Hertz) in the burned area after IM Oxytocin or placebo injection will be obtained. The subject will place the wrist area that was exposed to the UV burn on the oscillatory device, the fixed vibratory frequency will begin and will be increased in intensity and the subject will inform the investigators when the first perception of vibration is felt. A recording of the intensity level will be documented in Hertz. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sustained Heat After IM Injection Non Dominant Arm | Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin or placebo injection. | From 21 minutes to 125 minutes |
| Change in Sustained Heat After IM Injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James C Eisenach, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin First, Then Saline Placebo | Intramuscular injection of oxytocin (Pitocin®), 10 IU on the first study day and of 1 ml saline placebo on the second study day Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection Saline: 1.5 ml preservative free saline for intramuscular injection |
| FG001 | Saline Placebo First, Then Oxytocin | Intramuscular injection of 1 ml saline placebo on the second study day and of oxytocin (Pitocin®), 10 IU on the second study day Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection Saline: 1.5 ml preservative free saline for intramuscular injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Study Day |
| |||||||||||||
| Second Study Day |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin First, Then Saline Placebo | Intramuscular injection of oxytocin (Pitocin®), 10 IU on the first study day and of 1 ml saline placebo on the second study day Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection Saline: 1.5 ml preservative free saline for intramuscular injection |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Vibration Frequency Detection Threshold (When Vibration is First Felt) After IM Injection | Vibration frequency detection threshold in the burned area after IM Oxytocin or placebo injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented. | Please note that the protocol was amended after the first 5 participants. The first 5 participants were tested for vibration FREQUENCY detection threshold and the last 5 participants were tested for vibration INTENSITY detection threshold. This outcome relates to the first 5 participants only. | Posted | Mean | Standard Deviation | Hz | From 5 minutes to 120 minutes |
|
5 Days
This is a randomized, blinded, cross over design with treatment with oxytocin one day and placebo on another. Following baseline measures on each of the two study days, participants received an intramuscular injection of oxytocin (Pitocin®) in its indicated dose of 10 IU (17 μg) or an equivalent volume of saline.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxytocin | Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Eisenach | Wake Forest Health Sciences | 3367164182 | eisenach@wakehealth.edu |
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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 29, 2019 | Aug 18, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2019 | Jan 29, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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Double blinded crossover treatment with oxytocin and placebo (saline)
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Participant, Investigator and outcomes assessor will be blinded. Research Pharmacist will prepare the study medication administration and hold the randomization.
| Saline | Drug | 1.5 ml preservative free saline for intramuscular injection |
|
| From 5 minutes to 65 minutes |
Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 40 degree Celsius temperature applied to the site of the UV burn after IM Oxytocin or placebo injection. |
| From 36 minutes to 40 minutes |
| Change in Sustained Heat After IM Oxytocin or Placebo Injection (Lower Leg) | Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Oxytocin or placebo injection. | From 21 minutes to 65 minutes |
| NOT COMPLETED |
|
| Saline Placebo First, Then Oxytocin |
Intramuscular injection of 1 ml saline placebo on the second study day and of oxytocin (Pitocin®), 10 IU on the second study day Oxytocin: 10 IU oxytocin (Pitocin) for intramuscular injection Saline: 1.5 ml preservative free saline for intramuscular injection |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Placebo | Saline: 1.5 ml preservative free saline for intramuscular injection |
|
|
|
| Primary | Change in Pain Threshold (the Point Where Pain is First Perceived) to a Punctate Mechanical Stimulus After IM Injection. | Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin or Placebo injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented. | Please note that the protocol was amended after the first 5 participants. The first 5 participants were tested for pain THRESHOLD to mechanical stimulation and the last 5 participants were tested for degree of pain INTENSITY to a fixed mechanical stimulation. This outcome relates to the first 5 participants only. | Posted | Mean | Standard Deviation | grams | From 5 minutes to 120 minutes |
|
|
|
|
| Primary | Change in Hypersensitivity to Von Frey Filament (225 milliNewton) After IM Injection. | Hypersensitivity in the burned area after IM Oxytocin or placebo injection will be obtained by using a von Frey filament (small filament that is similar to a paint brush bristle). The skin will be touched with the filament and the participant will state when sensitivity is perceived and the area marked and measured in centimeters squared. | Please note that the protocol was amended after the first 5 participants. The first 5 participants were tested for pain THRESHOLD to mechanical stimulation and the last 5 participants were tested for degree of pain INTENSITY to a fixed mechanical stimulation. This outcome relates to the last 5 participants only. | Posted | Mean | Standard Deviation | cm^2 | From 5 minutes to 65 minutes |
|
|
|
|
| Primary | Change in Vibration Frequency Detection of Fixed Frequency (When Vibration is First Felt) After IM Injection | Vibration frequency detection of a fixed frequency (256 Hertz) in the burned area after IM Oxytocin or placebo injection will be obtained. The subject will place the wrist area that was exposed to the UV burn on the oscillatory device, the fixed vibratory frequency will begin and will be increased in intensity and the subject will inform the investigators when the first perception of vibration is felt. A recording of the intensity level will be documented in Hertz. | Please note that the protocol was amended after the first 5 participants. The first 5 participants were tested for vibration FREQUENCY detection threshold and the last 5 participants were tested for vibration INTENSITY detection threshold. This outcome relates to the last 5 participants only. | Posted | Mean | Standard Deviation | Hz | From 5 minutes to 65 minutes |
|
|
|
|
| Secondary | Change in Sustained Heat After IM Injection Non Dominant Arm | Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin or placebo injection. | Please note that the protocol was amended after the first 5 participants. The first 5 participants were tested for pain report to sustained heat applied to the ARM and the last 5 participants were tested for pain report to sustained heat applied to the LEG. This outcome relates to the first 5 participants only. | Posted | Mean | Standard Deviation | units on a scale | From 21 minutes to 125 minutes |
|
|
|
|
| Secondary | Change in Sustained Heat After IM Injection | Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 40 degree Celsius temperature applied to the site of the UV burn after IM Oxytocin or placebo injection. | Please note that the protocol was amended after the first 5 participants. Only the last 5 participants were tested for pain report to sustain heat applied at the site of the UV-B burn. | Posted | Mean | Standard Deviation | score on a scale | From 36 minutes to 40 minutes |
|
|
|
|
| Secondary | Change in Sustained Heat After IM Oxytocin or Placebo Injection (Lower Leg) | Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Oxytocin or placebo injection. | Please note that the protocol was amended after the first 5 participants. The first 5 participants were tested for pain report to sustained heat applied to the ARM and the last 5 participants were tested for pain report to sustained heat applied to the LEG. This outcome relates to the last 5 participants only. | Posted | Mean | Standard Deviation | score on a scale | From 21 minutes to 65 minutes |
|
|
|
|
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Placebo | Saline: 1.5 ml preservative free saline for intramuscular injection | 0 | 10 | 0 | 10 | 0 | 10 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |