NCT07053774 Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain
| NCT ID | NCT07053774 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Pain, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2026-06-20 |
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 24 participants in total. It began in 2025-11-05 with a primary completion date of 2026-06-20.
⚠ 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 research study is to find out how well oxytocin works to reduce pain. Oxytocin will be given intravenously (IV) and as a nasal spray. The study team also hopes to find out if the participants age, weight, or sex effects how well the study drug works. Participants will be exposed to a heater on the skin at a training visit and rate how much pain different temperatures cause. On two separate visits, participants will use a nasal spray and get an IV infusion. After the IV and nasal spray, participants will rate the pain of the same skin heating temperature at various time points for 4 hours.
Eligibility Criteria
Inclusion Criteria: * Male or female \> 18 and ≤75 years of age, Body Mass Index (BMI) \<40. * Generally in good health as determined by the Principal Investigator based on prior medical history, and as assessed to be American Society of Anesthesiologists physical status 1, 2, or 3. Exclusion Criteria: * Recent (\<3 months) nasal surgery or chronic conditions requiring daily intranasal (IN) medications * Hypersensitivity to any ingredient in Pitocin® (marketed preparation of oxytocin for parenteral injection) * Latex allergy * Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (e.g., active gynecologic disease in which increased tone would be detrimental such as uterine fibroids with ongoing bleeding) * Women who are pregnant, are currently nursing or lactating, or have been pregnant within 2 years * Neuropathy, chronic pain (located in any body location that is being treated), diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis. * Current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval. * 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, serotonin selective reuptake inhibitors (SSRI's), monamine oxidase inhibitors (MAOI), or the recreational drug ecstasy.
Contact & Investigator
James C Eisenach, MD
PRINCIPAL INVESTIGATOR
Atrium Health Wake Forest Baptist
Frequently Asked Questions
Who can join the NCT07053774 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pain, Acute. 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 NCT07053774 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 NCT07053774 currently recruiting?
Yes, NCT07053774 is actively recruiting participants. Contact the research team at eisenach@wakehealth.edu for enrollment information.
Where is the NCT07053774 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT07053774 clinical trial?
NCT07053774 is sponsored by Wake Forest University Health Sciences. The principal investigator is James C Eisenach, MD at Atrium Health Wake Forest Baptist. The trial plans to enroll 24 participants.