Pain, AcutePhase 2NCT07053774
Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain
A Phase 2 study testing Intravenous oxytocin and Intranasal oxytocin in people with Pain, Acute, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Intravenous oxytocin and Intranasal oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2025to 1 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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
- Being tested
- Intravenous oxytocin, Intravenous placebo, Intranasal oxytocin, Intranasal placebo
- Keywords
- healthy volunteers, pain control, oxytocin
- Medical subject headings
- Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous oxytocinDrug
Also called Pitocin
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 placeboDrug
Also called Normal saline
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 oxytocinDrug
Also called Pitocin
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 placeboDrug
Also called Excipients: chlorobutanol, methylparaben, propylparaben, dibasic sodium phosphate, anhydrous citric acid, sorbitol, glycerin, and sterile water
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 group | Role | What they receive |
|---|---|---|
| Intravenous (IV) oxytocin and intranasal (IN) placebo first | Experimental | 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.. Receives: Drug: Intravenous oxytocin; Drug: Intravenous placebo; Drug: Intranasal oxytocin; Drug: Intranasal placebo |
| Intravenous (IV) placebo and intranasal (IN) oxytocin first | Experimental | 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. Receives: Drug: Intravenous oxytocin; Drug: Intravenous placebo; Drug: Intranasal oxytocin; Drug: Intranasal placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scale Score - End of 5-minute Skin Heating
Change in verbal pain scale score. Range is 0-10. 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable.
Measured: Baseline Up to Hour 4.5
Pain Scale Score - During Skin Heating
Verbal pain scale range is 0-10. 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable.
Measured: Minute 5 During Skin Heating
Secondary outcomes (4)
Pain Scale Score - During Skin Heating
Verbal pain scale range is 0-10. 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable.
Measured: Minute 1 During Skin Heating
Pain Scale Score - During Skin Heating
Verbal pain scale range is 0-10. 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable.
Measured: Minute 2 During Skin Heating
Pain Scale Score - During Skin Heating
Verbal pain scale range is 0-10. 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable.
Measured: Minute 3 During Skin Heating
Pain Scale Score - During Skin Heating
Verbal pain scale range is 0-10. 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable.
Measured: Minute 4 During Skin Heating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start5 Nov 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will receive an intravenous (IV) infusion of study drug and self-administer intranasal study drug. At study visit two some participants will receive IV saline (placebo) and oxytocin (48 IU) intranasally and some will receive IV oxytocin (20 IU) saline (placebo) intranasally. At visit three, participants will receive the opposite treatment sequence they received at visit 2. The order of study days will be randomized.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James C Eisenach, MD, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053774
- Sponsor's protocol ID
- IRB00134089
- Other IDs
- 40010559
- Status last verified
- Jun 2026
- First submitted
- 27 Jun 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain
- ClinicalTrials.gov ID
- NCT07053774
- Acronym / sponsor ID
- IRB00134089
- Conditions
- Pain, Acute
- Keywords
- healthy volunteers, pain control, oxytocin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant will receive an intravenous (IV) infusion of study drug and self-administer intranasal study drug. At study visit two some participants will receive IV saline (placebo) and oxytocin (48 IU) intranasally and some will receive IV oxytocin (20 IU) saline (placebo) intranasally. At visit three, participants will receive the opposite treatment sequence they received at visit 2. The order of study days will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Intravenous (IV) oxytocin and intranasal (IN) placebo first | Experimental | Drug: Intravenous oxytocin, Drug: Intravenous placebo, Drug: Intranasal oxytocin, Drug: Intranasal placeboOn 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.. |
| Intravenous (IV) placebo and intranasal (IN) oxytocin first | Experimental | Drug: Intravenous oxytocin, Drug: Intravenous placebo, Drug: Intranasal oxytocin, Drug: Intranasal placeboOn 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous oxytocinAlso: PitocinOxytocin, 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 (IV) oxytocin and intranasal (IN) placebo first, Intravenous (IV) placebo and intranasal (IN) oxytocin first |
| Intravenous placeboAlso: Normal salineSaline 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 | Intravenous (IV) oxytocin and intranasal (IN) placebo first, Intravenous (IV) placebo and intranasal (IN) oxytocin first |
| Intranasal oxytocinAlso: PitocinOxytocin 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 | Intravenous (IV) oxytocin and intranasal (IN) placebo first, Intravenous (IV) placebo and intranasal (IN) oxytocin first |
| Intranasal placeboAlso: Excipients: chlorobutanol, methylparaben, propylparaben, dibasic sodium phosphate, anhydrous citric acid, sorbitol, glycerin, and sterile waterPlacebo (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. | Drug | Intravenous (IV) oxytocin and intranasal (IN) placebo first, Intravenous (IV) placebo and intranasal (IN) oxytocin first |
Primary outcome
Pain Scale Score - End of 5-minute Skin Heating
Time frame: Baseline Up to Hour 4.5
Change in verbal pain scale score. Range is 0-10. 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable.
Pain Scale Score - During Skin Heating
Time frame: Minute 5 During Skin Heating
Verbal pain scale range is 0-10. 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable.
4 secondary outcomes
Pain Scale Score - During Skin Heating
Time frame: Minute 1 During Skin Heating
Pain Scale Score - During Skin Heating
Time frame: Minute 2 During Skin Heating
Pain Scale Score - During Skin Heating
Time frame: Minute 3 During Skin Heating
Pain Scale Score - During Skin Heating
Time frame: Minute 4 During Skin Heating
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C Eisenach, MD principal investigator
Atrium Health Wake Forest Baptist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous oxytocin and Intranasal oxytocin in people with Pain, Acute, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scale Score - End of 5-minute Skin Heating (time frame: Baseline Up to Hour 4.5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.