Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07053774
Phase
PHASE2
Status
Recruiting
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Conditions

  • Pain, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Intravenous oxytocin — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 5, 2025
Status verified
May 2026
Primary completion
Jun 20, 2026
Completion
Jun 20, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Intravenous (IV) oxytocin and intranasal (IN) placebo first
    On Visit 2 participants will receive IV infusion of oxytocin. At the beginning of the IV infusion, the participant will self-administer IN placebo. On Visit 3 participants will receive IV infusion of placebo. At the beginning of the IV infusion, the participant will self-administer IN oxytocin..
  • Experimental: Intravenous (IV) placebo and intranasal (IN) oxytocin first
    On Visit 2 participant will receive IV infusion of placebo. At the beginning of the IV infusion, the participants will self-administer IN oxytocin. On Visit 3 participants will receive IV infusion of oxytocin. At the beginning of the IV infusion, the participant will self-administer IN placebo.

Primary Outcome Measure

Pain Scale Score - End of 5-minute Skin Heating [ Time Frame: Baseline Up to Hour 4.5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157
Regina Curry, RN
[email protected]
336-716-4294
James C Eisenach, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Winston-Salem, NC

By research site
Atrium Health Wake Forest Baptist· Winston-Salem, NC

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