Peripheral Oxytocin and Touch

Healthy Adults Clinical Trial

— POPP  

Official title:

Effect of Peripheral Oxytocin on Touch Pleasantness and Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05326776
• Other study ID #: 802467
• Status: Completed
• Phase: Phase 2
• Start date: April 5, 2023
• Est. completion date: August 3, 2023

Study information

• Verified date: November 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 3, 2023
• Est. primary completion date: August 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Between the ages of 18 and 65 years old

2. Fluent in English

3. Healthy

Exclusion Criteria:

4. Sensory or motor nerve deficit

5. Acute or chronic pain

6. 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).

7. 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

8. Unstable psychiatric conditions

9. Needle phobia or history of fainting

10. Current use of opiate medication(s)

11. Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®

12. Currently pregnant or pregnant within the last two years

13. Currently nursing or lactating

14. Current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval

15. Past or current history of hyponatremia or at risk for hyponatremia

16. 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

17. Latex allergy

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	ACTRI	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean pleasantness rating of gentle brushing	Touch pleasant/unpleasantness ratings will be assessed in response to slow gentle brushing using a Visual Analog Scale with anchors of "Extremely unpleasant" to "Neutral" to "Extremely pleasant." Change in mean rating of slow brushing will be compared between the oxytocin and placebo sessions.	Day 1 and Day 2
Primary	Change in mechanical threshold	Change in first percept of sharpness using standard set of weighted pinprick stimuli will be compared between the oxytocin and placebo sessions.	Day 1 and Day 2
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 used. Change in mean rating will be compared between the oxytocin and placebo sessions.	Day 1 and Day 2
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.	Day 1 and Day 2
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.	Day 1 and Day 2
Secondary	Heat pain ratings	Three 10s trials of the individually calibrated heat stimulus rated 70/100 will be rated using using a Visual Analog Scale rating scale with anchors "No pain" to "Most intense pain imaginable."	Day 1 and Day 2
Secondary	Anxiety using the State-Trait Anxiety Inventory	The investigators will measure anxiety levels using the State-Trait Anxiety Inventory. This measure will be included in a linear regression model to determine whether this measure significantly predicts effects of oxytocin on touch perception.	Day 1
Secondary	Pain Anxiety using the Pain Anxiety Symptoms Scale short form	The investigators will measure pain anxiety levels using the Pain Anxiety Symptoms Scale short form. This measure will be included in a linear regression model to determine whether this measure significantly predicts effects of oxytocin on touch perception.	Day 1
Secondary	Interoceptive Sensibility using the Multidimensional Assessment of Interoceptive Awareness	The investigators will measure interoceptive sensibility using the Multidimensional Assessment of Interoceptive Awareness. This measure will be included in a linear regression model to determine whether this measure significantly predicts effects of oxytocin on touch perception.	Day 1
Secondary	Attention to body using the The Body Awareness Questionnaire	The investigators will measure attention to the body using the The Body Awareness Questionnaire. This measure will be included in a linear regression model to determine whether this measure significantly predicts effects of oxytocin on touch perception.	Day 1
Secondary	Autistic traits using the Autism Quotient	The investigators will measure autistic traits using the Autism Quotient. This measure will be included in a linear regression model to determine whether this measure significantly predicts effects of oxytocin on touch perception.	Day 1
Secondary	Mood using the Profile of Mood States Questionnaire	The investigators will measure mood using the Profile of Mood States Questionnaire. This measure will be included in a linear regression model to determine whether this measure significantly predicts effects of oxytocin on touch perception.	Day 1