Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Pain, Acute
Interventions
DRUG

Intravenous oxytocin

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 placebo

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

Intranasal oxytocin

Oxytocin will be self-administered at the time the first IV infusion begins as a single 0.1 mL spray (12 IU) in each nostril followed in 5 min by another spray in each nostril. The total dose of oxytocin is 48 IU.

DRUG

Intranasal placebo

Placebo (solution containing the excipients in the oxytocin solution but without oxytocin) will be self-administered at the time the first IV infusion begins as a single 0.1 mL spray in each nostril followed in 5 min by another spray in each nostril.

Trial Locations (1)

27157

Atrium Health Wake Forest Baptist, Winston-Salem

All Listed Sponsors
lead

Wake Forest University Health Sciences

OTHER