NCT07409753 Effects Of Intravenous Oxytocin On Peripheral Sensory Afferents Using Microneurography
| NCT ID | NCT07409753 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Acute Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-10-22 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-10-22 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
James Eisenach, MD
STUDY CHAIR
Atrium Health Wake Forest University School of Medicine
Frequently Asked Questions
Who can join the NCT07409753 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Acute Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07409753 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07409753 currently recruiting?
Yes, NCT07409753 is actively recruiting participants. Contact the research team at hakan.olausson@liu.se for enrollment information.
Where is the NCT07409753 trial being conducted?
This trial is being conducted at Linköping, Sweden.
Who is sponsoring the NCT07409753 clinical trial?
NCT07409753 is sponsored by Wake Forest University Health Sciences. The principal investigator is James Eisenach, MD at Atrium Health Wake Forest University School of Medicine. The trial plans to enroll 60 participants.