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Peripheral Oxytocin and Touch (POPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05326776
Recruitment Status : Not yet recruiting
First Posted : April 14, 2022
Last Update Posted : April 14, 2022
Sponsor:
Information provided by (Responsible Party):
Laura Case, University of California, San Diego

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
Healthy Adults Drug: Pitocin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : May 1, 2022
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

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.




Primary Outcome Measures :
  1. Change in mean pleasantness rating of gentle brushing [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05326776


Contacts
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Contact: Laura Case, PhD 858-246-4968 lcase@health.ucsd.edu

Sponsors and Collaborators
University of California, San Diego
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Responsible Party: Laura Case, Adjunct Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05326776    
Other Study ID Numbers: 802467
First Posted: April 14, 2022    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data may be shared with other researchers per request.
Supporting Materials: Study Protocol
Time Frame: Upon study completion for as long as possible.
Access Criteria: For academic researchers conducting reviews, meta-analyses, or secondary analyses.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs