Effects Of Intravenous Oxytocin On Peripheral Sensory Afferents Using Microneurography

NCT07409753 | Recruiting Phase 2 DMC

• 3 other identifiers: P01-119159 Microneur. StudyP01NS1191592024-519670-39-00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if oxytocin reduces pain in a small area of skin after pulses of non-burning heat by changing how nerves in the heated area react to pressing a thin, bendable plastic bristle and a thick, non-bending plastic bristle in adult, healthy participants. The man questions it aims to answer are: Does oxytocin increase the number of times a fiber which normally responds only to the thin bristle fires (sends a signal) after the heat pulses. Does oxytocin raise the number of times a fiber which normally responds only to the thick bristle fires (sends a signal) after the heat pulses. Researchers will compare oxytocin to a placebo (a look-alike substance that contains no drug) to see if oxytocin ABC works to change how nerves react to light touch and painful pressing in an area of sensitized skin. Participants will: Receive an intravenous injection of oxytocin or placebo on one occasion On the same day, a needle will be put near nerve fibers to record their firing before and after a few cycles of short heating of the skin.

Conditions

Acute Pain

Keywords

healthy volunteers; pain control; oxytocin

Outcome Measures

Primary Outcomes (1)

• Number of nerve fiber discharges with von Frey filament application

  The number of nerve fiber discharges in response to a 5 second application of a 20 mN force von Frey filament and to a 1000 mN force von Frey filament to the area of skin responding to sensory stimulation. These are measured twice, once before and once after skin inflammation induced by heat pulses.

  2-8 hours after start of the first IV infusion

Secondary Outcomes (7)

• Verbal pain intensity score with von Frey filament application

  2-8 hours after start of the first IV infusion

• Pattern of nerve fiber discharges with von Frey filament application

  2-8 hours after start of the first IV infusion

• Number of nerve fiber burst discharges with tuning fork application

  2-8 hours after start of the first IV infusion

• Number of nerve fiber discharges with warming and cooling

  2-8 hours after start of the first IV infusion

• Number of nerve fiber discharges with soft brushing

  2-8 hours after start of the first IV infusion

Other Outcomes (7)

• Exploratory outcome: Score on Digit Symbol Substitution Test (DSST)

  1 hour before to 2 hr after start of the first IV infusion

• Exploratory outcome: Digit Span Test (DST)

  1 hour before to 2 hr after start of the first IV infusion

• Exploratory outcome: Rey Auditory Verbal Learning Test (RAVLT)

  30-60 minutes after completing the second IV infusion

Study Arms (2)

Intravenous Oxytocin

EXPERIMENTAL

Oxytocin, 10 International Units (IU) will be administered by IV infusion over 30 minutes and, 30 minutes later, a second 10 IU will be administered over 30 min, for a total dose of 20 IU. The first infusion will be at a rate of 0.125 IU/min for the first 5 min, then at 0.375 IU/min for the remaining 25 min. The second 30-min infusion will be at a fixed rate of 0.333 IU/min.

Drug: Intravenous Oxytocin

Intravenous Placebo

PLACEBO COMPARATOR

Saline will be administered as two 30-min IV infusions separated by 30-min, using the same volume of infusion solution and rates of administration as in the intravenous oxytocin intervention.

Drug: Intravenous Placebo

Interventions

Intravenous Oxytocin DRUG

Intravenous oxytocin, 20 IU will be administered via two 30-minute infusions separated by 30 minutes

Also known as: Oxytocin-Grindeks

Intravenous Oxytocin

Intravenous Placebo DRUG

Intravenous placebo will be infused in the same volume and timing as the intravenous oxytocin intervention

Also known as: Saline

Intravenous Placebo

Eligibility Criteria

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

You may qualify if:

• In good health as determined by the Principal Investigator (PI) or co-investigators based on prior medical history, current psychiatric assessment, and clinical assessment of lab tests.
• Female participants of child-bearing potential including those \< 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.
• Normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication.
• Proficient in Swedish or English

You may not qualify if:

• Hypersensitivity, allergy, or a history of significant reaction to any ingredients of the active drug (Oxytocin Grindeks® 8.7 microgram/ml solution) or the placebo (Sodium Chloride , ATC code: V07AB).
• Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the PI, would place the participant at increased risk (active gynecologic disease in which increased uterine tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the participant's compliance with study procedures, or compromise the quality of the data.
• Women who are pregnant (positive result for urine pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years.
• Body Mass Index (BMI) \> 30
• Participants with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
• Participants with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval.
• Participants with past or current history of hyponatremia or at risk for hyponatremia; anyone taking thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, antidepressants (SSRI's or MAOI), or the recreational drug ecstasy.
• Participants with a known latex allergy.
• Participants with substances use disorders or any other psychiatric disorder(s).
• Participant with high risk of fainting episodes.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Linkoeping University: collaborator

Study Sites (1)

Linköping University

Linköping, 58183, Sweden

RECRUITING

MeSH Terms

Conditions

Acute Pain; Agnosia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• James Eisenach, MD

  Atrium Health Wake Forest University School of Medicine

  STUDY CHAIR

Central Study Contacts

Hakan Olausson, MD, PhD

CONTACT

+46 13286788; hakan.olausson@liu.se

Saad Nagi, PhD

CONTACT

+46 13286823; saad.nagi@liu.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Linkoeping University (Linkoeping, Sweden) research pharmacy will prepare solutions and dispense them on the day of each study using a randomization stratified by sex that will be concealed until the end of the clinical trial.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will be randomized to receive an intravenous (IV) infusion of study drug, either IV saline (placebo) or IV oxytocin (20 IU).

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 13, 2026
• Study Start: October 22, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 8, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)