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RECRUITING

NCT07409753

PHASE2

Effects Of Intravenous Oxytocin On Peripheral Sensory Afferents Using Microneurography

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-10-22

Completion Date

2027-06-08

Last Updated

2026-02-13

Healthy Volunteers

Yes

Conditions

Acute Pain

Interventions

DRUG

Intravenous Oxytocin

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

DRUG

Intravenous Placebo

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

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.

Locations (1)

Linköping University

Linköping, Sweden