Study on the Effects of Oxytocin Infusion on Sensory Nerves in Healthy Volunteers

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What is this study about?

This clinical trial is focused on studying the effects of the medication oxytocin on healthy individuals. Oxytocin is a hormone that is often associated with social bonding and childbirth. In this study, it will be administered through an intravenous infusion, which means it will be given directly into the bloodstream. The trial will also use a placebo for comparison purposes. The main goal of the study is to understand how oxytocin affects the body’s sensory nerves, particularly those that respond to touch and inflammation.

Participants in the study will receive either oxytocin or a placebo and will undergo a series of tests to measure their sensory responses. These tests will include examining how the skin’s nerves react to touch and heat-induced inflammation. The study will also look at how oxytocin might influence cognitive functions, such as memory and information processing, as well as subjective experiences like the pleasantness of touch.

The trial is designed to be triple-blind, meaning that neither the participants, the researchers, nor the data analysts will know who is receiving oxytocin and who is receiving the placebo. This approach helps ensure that the results are unbiased. The study will take place over a short period, with participants being monitored closely to observe any changes in their sensory and cognitive responses. The findings from this research could provide valuable insights into the potential uses of oxytocin in medical treatments.

1 joining the study

Upon joining the study, you will be required to provide informed consent, confirming your understanding and agreement to participate in the trial.

You must meet the inclusion criteria, which include being between 18-65 years old, in good health, and proficient in Swedish or English.

2 preparation for the trial

Before the trial begins, you must abstain from recreational or illicit substances, including amphetamines, cannabis, opiates, and benzodiazepines, for 24 hours.

You should also avoid caffeine, alcohol, and nicotine for at least 12 hours before the experiment.

If you are a fertile female, a negative urine pregnancy test is required at the start of the study session.

3 administration of medication

During the trial, you will receive an intravenous infusion of oxytocin or a placebo (saline solution).

The infusion will be administered as a solution for injection or infusion.

4 monitoring and assessment

Your response to the medication will be monitored using a technique called microneurography, which measures nerve activity.

The primary focus will be on the number of action potentials, or spikes, generated by sensory nerves in response to skin indentation after heat-induced inflammation.

5 evaluation of cognitive and sensory responses

Your cognitive performance, including information processing speed, learning, memory, and verbal working memory, will be assessed.

Psychophysical tests will be conducted to quantify touch pleasantness and inflammation.

Who Can Join the Study?

  • Age between 18 and 65 years, and willing to provide informed consent.
  • In good health as determined by medical history, ECG (a test that checks your heart’s electrical activity), and lab tests. The final decision will be made by the lead doctor.
  • No use of recreational or illegal drugs (like amphetamines, cannabis, opiates, and benzodiazepines) 24 hours before and during the experiment. This will be checked through medical history and tests on blood and urine. Participants should also avoid caffeine, alcohol, and nicotine for at least 12 hours before the experiment.
  • Ability to speak and understand Swedish or English.
  • Females who can have children must have a negative urine pregnancy test at the start of the study. If they are sexually active and have not been surgically sterilized, they must agree to use a reliable method of birth control during the study.

Who Cannot Join the Study?

  • Participants must be healthy. This means they should not have any ongoing medical conditions.
  • Participants must be within a specific age range. This study is for adults, so participants should be between 18 and 65 years old.
  • Participants must not be part of a vulnerable population. This means they should not be in a situation where they are unable to make informed decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Region Oestergoetland Linkoping Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Recruiting
01.07.2025

Trial locations

Investigated drugs:

Oxytocin is a hormone that is naturally produced in the body, often associated with social bonding, childbirth, and lactation. In this clinical trial, oxytocin is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The purpose of using oxytocin in this study is to see how it affects certain nerve endings in the skin, especially when the skin is inflamed. Researchers are interested in understanding if oxytocin can change how these nerves respond to touch and heat, and how it might influence cognitive functions and personal feelings.

Acute Inflammation – Acute inflammation is the body’s immediate response to harmful stimuli, such as pathogens or injury. It is characterized by redness, heat, swelling, pain, and loss of function in the affected area. This process involves the release of chemicals that increase blood flow and attract immune cells to the site of injury or infection. The purpose of acute inflammation is to eliminate the initial cause of cell injury, clear out damaged cells, and establish a repair process. It typically resolves within a few days, once the harmful stimuli are removed. If the inflammation persists, it may lead to chronic inflammation.

Trial ID:
2024-519670-39-00
Protocol code:
PAINOXY
Trial Phase:
Human Pharmacology (Phase I) – Other

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