Peripheral Oxytocin and Touch

NCT05326776 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 802467
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (3)

• Change in Mean Pleasantness Rating of Gentle Brushing

  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).

  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

  "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.

  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

  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.

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

Secondary Outcomes (3)

• Pressure Pain Threshold

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

• Heat Pain Threshold

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

• Heat Pain Ratings

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

Study Arms (2)

Order 1

EXPERIMENTAL

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

Drug: Pitocin

Order 2

EXPERIMENTAL

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

Drug: Pitocin

Interventions

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.

Order 1; Order 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18 and 65 years old
• Fluent in English
• Healthy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

ACTRI

La Jolla, California, 92115, United States

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Laura Case
• Organization: UC San Diego

lcase@health.ucsd.edu

858-246-4968

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 14, 2022
• Study Start: April 5, 2023
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: December 31, 2024
• Results First Posted: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon study completion for as long as possible.
• Access Criteria: For academic researchers conducting reviews, meta-analyses, or secondary analyses.

Locations

US (1)