Intravenous oxytocin to change how skin nerves respond to heat and touch

Examining The Effects Of Intravenous Oxytocin Infusion On Peripheral Sensory Afferents Using Microneurography Technique In Healthy Volunteers: A Triple-Blind, Randomized, Placebo-Controlled Trial

This study will test whether a single IV dose of oxytocin can reduce localized heat-induced pain and change how peripheral nerves respond in healthy adults aged 18–65.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Wake Forest University Health Sciences (Academic / other)
• Locations: 1 site (Linköping)
• Trial ID: NCT07409753 on ClinicalTrials.gov

What this trial studies

This is a randomized, triple-masked, placebo-controlled Phase 2 trial in healthy adult men and women aged 18–65 conducted at Linköping University. Participants receive a single IV administration of oxytocin (20 IU) or placebo delivered as two 30-minute infusions with a very slow initial rate to limit early side effects and preserve blinding. Investigators use microneurography to record action potentials from peripheral sensory fibers while applying brief non-burning heat pulses and probing the skin with thin and thick plastic bristles to measure changes in nerve firing and pain responses. Outcomes compare nerve fiber firing rates and pain reports between oxytocin and placebo-treated visits.

Who should consider this trial

Good fit: Healthy adults aged 18–65 who are fluent in Swedish or English, have normal blood pressure and heart rate, and meet contraception and other study safety requirements are the intended participants.

Not a fit: People with chronic pain conditions, pregnant or breastfeeding women, those with cardiovascular instability, or anyone allergic to oxytocin or study ingredients are unlikely to benefit from this healthy-volunteer mechanistic study.

Why it matters

Potential benefit: If successful, this could point to a new peripheral mechanism for reducing localized acute pain and guide development of oxytocin-based pain treatments.

How similar studies have performed: Some prior human studies have reported analgesic effects of systemic or intranasal oxytocin, but using IV oxytocin with microneurography to measure peripheral afferent changes is novel and not well established.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where this trial is running

Linköping

• Linköping University — Linköping, Sweden (Recruiting)

Study contacts

• Study coordinator: Hakan Olausson, MD, PhD

Conditions Acute Pain; healthy volunteers; pain control; oxytocin