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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

3 criteria

  • 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.
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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.

What is already known about the treatment

Oxytocin – Oxytocin is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. Currently, oxytocin is being studied in clinical trials to understand its effects on sensory nerves in healthy individuals. It is primarily known for its role in childbirth and lactation, but this study explores its potential impact on sensory perception and inflammation. At the molecular level, oxytocin works by binding to specific receptors in the body, influencing nerve activity and possibly affecting how we perceive touch and pain. It is classified as a hormone and neurotransmitter, commonly associated with social bonding and reproductive functions.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-519670-39-00Protocol codePAINOXYEstimated enrolment60 patientsSponsorLinkopings Universitet

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