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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Peripheral Oxytocin and Touch

Short name POPP

NCTNCT05326776 (opens ClinicalTrials.gov in a new tab)Other id802467
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
20 participants (actual)
Sponsor
University of California, San Diego · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
5 Apr 2023
Primary completion
3 Aug 2023
Completion
3 Aug 2023
First posted
14 Apr 2022
Last update posted
31 Dec 2024
Conditions
Healthy Adults

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20232024
  1. Ph 2

    POPP

    NCT05326776

    5 Apr 2023 to 3 Aug 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • PitocinDrug

Arms2

  • Experimental

    Order 1

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

  • Experimental

    Order 2

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

Primary outcomes3

Outcomes the sponsor listed as primary.

  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)

    Registry description

    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)

    Registry description

    "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)

    Registry description

    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(3)

  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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)

Change in Mean Pleasantness Rating of Gentle Brushing

GroupValue (score on a scale)Spread
Oxytocin Session-8.723.0
Placebo Session-14.127.8
Primary outcomeMean· Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)

Change in Mechanical Threshold

GroupValue (mN)Spread
Oxytocin Session65.3143.1
Placebo Session63.2125.9
Primary outcomeMean· Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)

Change in Temporal Summation of Pinprick Stimuli

GroupValue (change in ratio of ratings on scales)Spread
Oxytocin Session0.150.63
Placebo Session-.021.3
Secondary and other outcome results(3)
Secondary outcomeMean· Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)

Pressure Pain Threshold

GroupValue (changes in pounds of force)Spread
Oxytocin Session0.131.9
Placebo Session0.581.5
Secondary outcomeMean· Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)

Heat Pain Threshold

GroupValue (changes in degrees Celsius)Spread
Oxytocin Session0.32.5
Placebo Session-0.291.3
Secondary outcomeMean· Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)

Heat Pain Ratings

GroupValue (score on a scale)Spread
Oxytocin Session-15.043.9
Placebo Session1.223.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Oxytocin SessionData from during the Oxytocin Session, regardless of order. 4mcg/2ml oxytocin was injected into the middle of the dorsal forearm.0 / 180 / 180 / 18
Placebo SessionData from during the Placebo Session, regardless of order. 2ml isotonic saline was injected into the forearm.0 / 180 / 180 / 18

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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