Peripheral Oxytocin and Touch (POPP)

University of California San Diego

Status and phase: Completed; Phase 2

Conditions: Healthy Adults

Treatments: Drug: Pitocin

Study type: Interventional

Funder types: Other

Identifiers

NCT05326776

802467

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Order 1

Experimental group

Description:

Participants will receive 4mcg/2ml oxytocin during Session 1 and 2ml isotonic saline during Session 2, injected into the forearm.

Treatment:

Drug: Pitocin

Order 2

Experimental group

Description:

Participants will receive 2ml isotonic saline during Session 1 and 4mcg/2ml oxytocin during Session 2, injected into the forearm.

Treatment:

Drug: Pitocin