Clinical trial NCT05326776: Peripheral Oxytocin and Touch
Official title: Effect of Peripheral Oxytocin on Touch Pleasantness and Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Adults
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


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

Primary outcomes:
measure: Change in Mean Pleasantness Rating of Gentle Brushing
timeFrame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
measure: Change in Mechanical Threshold
timeFrame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
measure: Change in Temporal Summation of Pinprick Stimuli
timeFrame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
Secondary outcomes:
measure: Pressure Pain Threshold
timeFrame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
measure: Heat Pain Threshold
timeFrame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
measure: Heat Pain Ratings
timeFrame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: ACTRI
state: California
Study officials:
References: