Clinical trial

Effect of Peripheral Oxytocin on Touch Pleasantness and Pain

Name
802467
Description
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.
Trial arms
Trial start
2023-04-05
Estimated PCD
2023-08-03
Trial end
2023-08-03
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Order 1, Order 2
Size
20
Primary endpoint
Change in mean pleasantness rating of gentle brushing
Day 1 and Day 2
Change in mechanical threshold
Day 1 and Day 2
Change in temporal summation of pinprick stimuli
Day 1 and Day 2
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2023-11-29

1 organization

1 product

1 indication

Product
Pitocin
Indication
Healthy Adults