POPP: Peripheral Oxytocin and Touch

Sponsor
University of California, San Diego (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05326776
Collaborator
(none)
20
2
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effect of Peripheral Oxytocin on Touch Pleasantness and Pain
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Order 1

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

Drug: 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.

Experimental: Order 2

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

Drug: 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.

Outcome Measures

Primary Outcome Measures

  1. Change in mean pleasantness rating of gentle brushing [Day 1 and Day 2]

    Touch pleasant/unpleasantness ratings will be assessed in response to slow gentle brushing using a Visual Analog Scale with anchors of "Extremely unpleasant" to "Neutral" to "Extremely pleasant." Change in mean rating of slow brushing will be compared between the oxytocin and placebo sessions.

  2. Change in mechanical threshold [Day 1 and Day 2]

    Change in first percept of sharpness using standard set of weighted pinprick stimuli will be compared between the oxytocin and placebo sessions.

  3. Change in temporal summation of pinprick stimuli [Day 1 and Day 2]

    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 used. Change in mean rating will be compared between the oxytocin and placebo sessions.

Secondary Outcome Measures

  1. Pressure pain threshold [Day 1 and Day 2]

    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.

  2. Heat pain threshold [Day 1 and Day 2]

    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 [Day 1 and Day 2]

    Three 10s trials of the individually calibrated heat stimulus rated 70/100 will be rated using using a Visual Analog Scale rating scale with anchors "No pain" to "Most intense pain imaginable."

  4. Anxiety using the State-Trait Anxiety Inventory [Day 1]

    The investigators will measure anxiety levels using the State-Trait Anxiety Inventory. This measure will be included in a linear regression model to determine whether this measure significantly predicts effects of oxytocin on touch perception.

  5. Pain Anxiety using the Pain Anxiety Symptoms Scale short form [Day 1]

    The investigators will measure pain anxiety levels using the Pain Anxiety Symptoms Scale short form. This measure will be included in a linear regression model to determine whether this measure significantly predicts effects of oxytocin on touch perception.

  6. Interoceptive Sensibility using the Multidimensional Assessment of Interoceptive Awareness [Day 1]

    The investigators will measure interoceptive sensibility using the Multidimensional Assessment of Interoceptive Awareness. This measure will be included in a linear regression model to determine whether this measure significantly predicts effects of oxytocin on touch perception.

  7. Attention to body using the The Body Awareness Questionnaire [Day 1]

    The investigators will measure attention to the body using the The Body Awareness Questionnaire. This measure will be included in a linear regression model to determine whether this measure significantly predicts effects of oxytocin on touch perception.

  8. Autistic traits using the Autism Quotient [Day 1]

    The investigators will measure autistic traits using the Autism Quotient. This measure will be included in a linear regression model to determine whether this measure significantly predicts effects of oxytocin on touch perception.

  9. Mood using the Profile of Mood States Questionnaire [Day 1]

    The investigators will measure mood using the Profile of Mood States Questionnaire. This measure will be included in a linear regression model to determine whether this measure significantly predicts effects of oxytocin on touch perception.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Between the ages of 18 and 65 years old

  2. Fluent in English

  3. Healthy

Exclusion Criteria:
  1. Sensory or motor nerve deficit

  2. Acute or chronic pain

  3. 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).

  4. 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

  5. Unstable psychiatric conditions

  6. Needle phobia or history of fainting

  7. Current use of opiate medication(s)

  8. Hypersensitivity, allergy, or significant reaction to any ingredient of PitocinĀ®

  9. Currently pregnant or pregnant within the last two years

  10. Currently nursing or lactating

  11. Current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval

  12. Past or current history of hyponatremia or at risk for hyponatremia

  13. 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

  14. Latex allergy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laura Case, Adjunct Professor, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT05326776
Other Study ID Numbers:
  • 802467
First Posted:
Apr 14, 2022
Last Update Posted:
Apr 14, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2022