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Completed

NCT Number: NCT05326776

Peripheral Oxytocin and Touch

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ACTRI

La Jolla, California, 92115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Mean Pleasantness Rating of Gentle Brushing

    Time frame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)

    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).

  2. Change in Mechanical Threshold

    Time frame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)

    "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.

  3. Change in Temporal Summation of Pinprick Stimuli

    Time frame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)

    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.

Secondary outcomes

  1. Pressure Pain Threshold

    Time frame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)

    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.

  2. Heat Pain Threshold

    Time frame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)

    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.

  3. Heat Pain Ratings

    Time frame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)

    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).

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Effect of Peripheral Oxytocin on Touch Pleasantness and Pain

Acronym: POPP

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2022
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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