NCT07053774

Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

This protocol will utilize a randomized, triple-masked, cross-over study design to compare intravenous (IV) to intranasal (IN) oxytocin administration for analgesia to an experimental pain stimulus in healthy volunteers. Equal numbers of adult men and women; ages 18-55 will be recruited. Participants will report to the research unit for three visits, 1) screening, informed consent, pregnancy test, and training to consistently rate pain from an FDA-approved device to test heat pain. The lowest temperature which causes a pain score of greater than 2 with 5 minutes of heating will be identified, 2) intravenous infusion and self-administered intranasal spray of study drug and 5-minute heat testing at intervals for 4 hours, 3) a repeat of the procedures done at visit two. Participants will receive intravenous oxytocin, 20 IU and intranasal placebo on one of these visits and intravenous placebo and intranasal oxytocin, 48 IU, on the other. Pain score at the end of 5-minute skin heating will be compared using mathematical modeling of the time course of change in each individual and in the study population as a whole. The effect, if any, on these models of participant age, sex, and weight will be explored.

Conditions

• Pain, Acute

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-05
• Primary completion: 2026-06-20
• Completion: 2026-06-20
• First posted: 2025-07-08
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study