Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Research shows that slow gentle skin stroking can activate special sensory nerves in the skin that elicit relaxing effects on the body and mind, similar to the effects of the hormone oxytocin. Studies also suggest that gentle stroking may even release oxytocin in the skin. However, we do not know what oxytocin does in the skin and how it affects nerves that send pleasant touch or pain signals to the brain. The proposed study will determine how individuals perceive gentle stroking and experimental pain before and after a skin injection of oxytocin compared to a placebo injection.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Order 1 | Experimental | Participants will receive 4mcg/2ml oxytocin during Session 1 and 2ml isotonic saline during Session 2, injected into the forearm. |
|
| Order 2 | Experimental | Participants will receive 2ml isotonic saline during Session 1 and 4mcg/2ml oxytocin during Session 2, injected into the forearm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitocin | Drug | At each session, 4mcg/2ml oxytocin or 2ml isotonic saline (0.9% sodium chloride; placebo control) will be injected into the middle of the dorsal forearm. Sessions will be separated by at least 48 hours to ensure drug clearance. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Pleasantness Rating of Gentle Brushing | Touch pleasant/unpleasantness ratings will be assessed in response to slow gentle brushing using a "Pleasantness/Unpleasantness" Visual Analog Scale with anchors of "Extremely unpleasant" (coded -100) to "Neutral" to "Extremely pleasant (coded 100)." Change in mean rating of slow brushing will be compared between the oxytocin and placebo sessions. Higher values indicate increased pleasantness (better outcome). | Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart) |
| Change in Mechanical Threshold | "Mechanical threshold" task. Change in first reported percept of sharpness from application of a standard set of weighted pinprick stimuli (minimum 8mN; maximum 512 mN) will be compared between the oxytocin and placebo sessions. An increased threshold indicates reduced sensitivity to mechanical pain. | Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart) |
| Change in Temporal Summation of Pinprick Stimuli | Temporal summation will be tested using a standard 256 milliNewtons (mN) pinprick stimulus applied for 10 repetitions. The participant will provide pain ratings for a single pinprick and for the 10 repetitions, using a Visual Analog Scale rating scale with anchors "No pain" to "Most intense pain imaginable." This procedure will be repeated 5 times and the mean pain rating for the repeated pinprick will be divided by the mean rating of the single pinprick to obtain the standard temporal summation ratio. Change in ratio will be compared between the oxytocin and placebo sessions. | Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart) |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure Pain Threshold | Pressure pain threshold will be tested using a pressure algometer placed over the dorsal forearm muscles, and pressure will be increased until pain is reported. When pain is reported, the pressure level (in pounds of force) is recorded as the outcome measure. | Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart) |
Not provided
Inclusion Criteria:
Between the ages of 18 and 65 years old
Fluent in English
Healthy
Exclusion Criteria:
Sensory or motor nerve deficit
Acute or chronic pain
Major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder) or a chronic systemic disease (e.g., diabetes).
Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
Unstable psychiatric conditions
Needle phobia or history of fainting
Current use of opiate medication(s)
Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
Currently pregnant or pregnant within the last two years
Currently nursing or lactating
Current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval
Past or current history of hyponatremia or at risk for hyponatremia
Current use of thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, Ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, selective serotonin reuptake inhibitors, monoamine oxidase inhibitora, or the recreational drug ecstasy
Latex allergy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACTRI | La Jolla | California | 92115 | United States |
Deidentified data may be shared with other researchers per request.
Upon study completion for as long as possible.
For academic researchers conducting reviews, meta-analyses, or secondary analyses.
Not provided
Screening was conducted prior to enrollment. No participants were excluded after enrollment.
Healthy adults were recruited from the local community as well as from our previous studies. Potential participants completed a telephone screening during which the study procedures were described, and eligibility criteria were reviewed.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Order 1 | Participants will receive 4mcg/2ml oxytocin during Session 1 and 2ml isotonic saline during Session 2, injected into the forearm. Pitocin: At each session, 4mcg/2ml oxytocin or 2ml isotonic saline (0.9% sodium chloride; placebo control) will be injected into the middle of the dorsal forearm. Sessions will be separated by at least 48 hours to ensure drug clearance. |
| FG001 | Order 2 | Participants will receive 2ml isotonic saline during Session 1 and 4mcg/2ml oxytocin during Session 2, injected into the forearm. Pitocin: At each session, 4mcg/2ml oxytocin or 2ml isotonic saline (0.9% sodium chloride; placebo control) will be injected into the middle of the dorsal forearm. Sessions will be separated by at least 48 hours to ensure drug clearance. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Order 1 | Participants will receive 4mcg/2ml oxytocin during Session 1 and 2ml isotonic saline during Session 2, injected into the forearm. Pitocin: At each session, 4mcg/2ml oxytocin or 2ml isotonic saline (0.9% sodium chloride; placebo control) will be injected into the middle of the dorsal forearm. Sessions will be separated by at least 48 hours to ensure drug clearance. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Mean Pleasantness Rating of Gentle Brushing | Touch pleasant/unpleasantness ratings will be assessed in response to slow gentle brushing using a "Pleasantness/Unpleasantness" Visual Analog Scale with anchors of "Extremely unpleasant" (coded -100) to "Neutral" to "Extremely pleasant (coded 100)." Change in mean rating of slow brushing will be compared between the oxytocin and placebo sessions. Higher values indicate increased pleasantness (better outcome). | All participants who completed both sessions. | Posted | Mean | Standard Deviation | score on a scale | Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart) |
|
Up to 3 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxytocin Session | Data from during the Oxytocin Session, regardless of order. 4mcg/2ml oxytocin was injected into the middle of the dorsal forearm. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laura Case | UC San Diego | 858-246-4968 | lcase@health.ucsd.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2023 | Oct 17, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 16, 2023 | Oct 17, 2024 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Heat Pain Threshold | Heat pain threshold (HPT) will be tested using a high-quality thermode. To establish HPT, the thermode will be placed on the arm at a baseline temperature of 32 Celsius and will be increased until the stimulus is reported as painful by the participant. The mean of three trials will be taken as the HPT. | Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart) |
| Heat Pain Ratings | Three 10s trials of the individually calibrated heat stimulus rated 70/100 will be rated using using a "Pain Intensity" Visual Analog Scale rating scale with anchors "No pain" (coded -100) to "Most intense pain imaginable (coded 100)." Higher scores indicate more intense pain (worse outcome). | Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart) |
| BG001 | Order 2 | Participants will receive 2ml isotonic saline during Session 1 and 4mcg/2ml oxytocin during Session 2, injected into the forearm. Pitocin: At each session, 4mcg/2ml oxytocin or 2ml isotonic saline (0.9% sodium chloride; placebo control) will be injected into the middle of the dorsal forearm. Sessions will be separated by at least 48 hours to ensure drug clearance. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo Session |
Data from during the Placebo saline Session, regardless of order. |
|
|
| Primary | Change in Mechanical Threshold | "Mechanical threshold" task. Change in first reported percept of sharpness from application of a standard set of weighted pinprick stimuli (minimum 8mN; maximum 512 mN) will be compared between the oxytocin and placebo sessions. An increased threshold indicates reduced sensitivity to mechanical pain. | All participants who completed both sessions. | Posted | Mean | Standard Deviation | mN | Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart) |
|
|
|
| Primary | Change in Temporal Summation of Pinprick Stimuli | Temporal summation will be tested using a standard 256 milliNewtons (mN) pinprick stimulus applied for 10 repetitions. The participant will provide pain ratings for a single pinprick and for the 10 repetitions, using a Visual Analog Scale rating scale with anchors "No pain" to "Most intense pain imaginable." This procedure will be repeated 5 times and the mean pain rating for the repeated pinprick will be divided by the mean rating of the single pinprick to obtain the standard temporal summation ratio. Change in ratio will be compared between the oxytocin and placebo sessions. | All participants who completed both sessions. | Posted | Mean | Standard Deviation | change in ratio of ratings on scales | Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart) |
|
|
|
| Secondary | Pressure Pain Threshold | Pressure pain threshold will be tested using a pressure algometer placed over the dorsal forearm muscles, and pressure will be increased until pain is reported. When pain is reported, the pressure level (in pounds of force) is recorded as the outcome measure. | All participants who completed both sessions. | Posted | Mean | Standard Deviation | changes in pounds of force | Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart) |
|
|
|
| Secondary | Heat Pain Threshold | Heat pain threshold (HPT) will be tested using a high-quality thermode. To establish HPT, the thermode will be placed on the arm at a baseline temperature of 32 Celsius and will be increased until the stimulus is reported as painful by the participant. The mean of three trials will be taken as the HPT. | All participants who completed both sessions. | Posted | Mean | Standard Deviation | changes in degrees Celsius | Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart) |
|
|
|
| Secondary | Heat Pain Ratings | Three 10s trials of the individually calibrated heat stimulus rated 70/100 will be rated using using a "Pain Intensity" Visual Analog Scale rating scale with anchors "No pain" (coded -100) to "Most intense pain imaginable (coded 100)." Higher scores indicate more intense pain (worse outcome). | All participants who completed both sessions. | Posted | Mean | Standard Deviation | score on a scale | Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart) |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Placebo Session | Data from during the Placebo Session, regardless of order. 2ml isotonic saline was injected into the forearm. | 0 | 18 | 0 | 18 | 0 | 18 |
Not provided
Not provided
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| male |
|