24
Participants
Start Date
November 1, 2025
Primary Completion Date
September 30, 2026
Study Completion Date
September 30, 2026
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.
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.
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.
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.
Atrium Health Wake Forest Baptist, Winston-Salem
Wake Forest University Health Sciences
OTHER