Acute PainPhase 2NCT05929339
Defining a PK and PD Model for Peripheral Analgesia After IV Oxytocin
A Phase 2 study testing Oxytocin in people with Acute Pain and Chronic Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about oxytocin ( a naturally occurring hormone made in the brain that transmits messages) and the effects it may have on thermal heat pain after intravenous administration. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Chronic Pain, Healthy Volunteer
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2023to 2 Oct 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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, American Society of Anesthesiologists physical status 1, 2, or 3.
- For healthy volunteers, normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication. For knee arthritis subjects, normal blood pressure or, for those with hypertension, pressure controlled with anti-hypertensives and with a resting heart rate 45-100 beats per minute.
- Female subjects of child-bearing potential and those < 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.
Who cannot join
- Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
- Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
- Women who are pregnant (positive result for serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years
- Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
- Subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval.
- Subjects with 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, SSRI's, MAOI, or the recreational drug ecstasy.
- Subjects with a known latex allergy.
- Subjects with a pain score rating of 1 or less during the initial training session to a 5 minute heating of 45°C- 47 °Celsius to the lower calf.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Defining a Pharmacokinetic and Pharmacodynamic Model for Peripheral Analgesia After Intravenous Oxytocin
The goal of this clinical trial is to learn about oxytocin ( a naturally occurring hormone made in the brain that transmits messages) and the effects it may have on thermal heat pain after intravenous administration. The main question it aims to define is the time course of change in pain score after a 5 minute heating of the skin administered at intervals during and following infusion of intravenous oxytocin in order to create a Pharmacokinetic and a Pharmacodynamic model for oxytocin-induced analgesia.
Participants will be asked to rate thermal heat temperatures before, during and after the intravenous infusion of oxytocin.
Read the detailed description
The primary objective is to define the time course of change in pain score after a 5 minute heating of the skin applied at intervals during and following infusion of intravenous oxytocin in order to create a Pharmacokinetic and Pharmacodynamic model for oxytocin-induced analgesia.
- Conditions
- Acute Pain, Chronic Pain, Healthy Volunteer
- Being tested
- Oxytocin
- Keywords
- Acute pain, Chronic Pain, Oxytocin
- Medical subject headings
- Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin
Intravenous oxytocin
| Study group | Role | What they receive |
|---|---|---|
| Verbal Pain Score at 10 Minutes | Other | Two 30 minute infusions of oxytocin, 10 IU, will be administered. The second infusion will be given 30 minutes after the completion of the first infusion.
In this arm the first primary outcome measure (verbal pain report at the end of 5 minutes of skin heating) is obtained at 10 minutes after starting the intervention, then every 15 minutes until 115 minutes and at 180 minutes after starting the intervention. The primary outcome is also measured on separate study visits 24 hours and between 5-7 days after starting the first oxytocin infusion. Receives: Drug: Oxytocin |
| Verbal Pain Score at 15 Minutes | Other | Two 30 minute infusions of oxytocin, 10 IU, will be administered. The second infusion will be given 30 minutes after the completion of the first infusion.
In this arm the first primary outcome measure (verbal pain report at the end of 5 minutes of skin heating) is obtained at 15 minutes after starting the intervention, then every 15 minutes until 120 minutes and at 180 minutes after starting the intervention. The primary outcome is also measured on separate study visits 24 hours and between 5-7 days after starting the first oxytocin infusion. Receives: Drug: Oxytocin |
| Verbal Pain Score at 20 Minutes | Other | Two 30 minute infusions of oxytocin, 10 IU, will be administered. The second infusion will be given 30 minutes after the completion of the first infusion.
In this arm the first primary outcome measure (verbal pain report at the end of 5 minutes of skin heating) is obtained at 20 minutes after starting the intervention, then every 15 minutes until 125 minutes and at 180 minutes after starting the intervention. The primary outcome is also measured on separate study visits 24 hours and between 5-7 days after starting the first oxytocin infusion. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Pain Score at the End of 5 Minutes of Skin Heating
Verbal pain score measured at one minute intervals during the 5 minute heating of the skin at intervals up to180 minutes after the initiation of the oxytocin infusions, then at 24 hours and 5-7 days after oxytocin infusions. The verbal pain score at the 5 minute measurement is the primary pharmacodynamic outcome for the purpose of modeling the pharmacokinetic-pharmacodynamic relationship. Note that the timing of the primary outcome differs among arms.
Pain intensity report will be recorded each minute during the heating of the skin to 45 - 47 degrees Celsius . Pain will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
Measured: 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start17 Aug 2023
- Primary completion2 Oct 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute PainStudies 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
- Parallel groups
- Model description
- All subjects will receive two 30-minute infusions of oxytocin, 10 IU. The second infusion will be given 30 minutes after the completion of the first infusion. The first 8 subjects report pain at the end of 5 minutes of skin heating at intervals beginning 15 minutes after starting the first infusion. The remaining subjects will be randomized to report pain at the end of 5 minutes of skin heating at intervals beginning at either 10 or 20 minutes after starting the first infusion.
- Masking
- None (open label)
- Enrolment
- 25 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, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929339
- Sponsor's protocol ID
- IRB00097699
- Other IDs
- 1P01NS119159-01A1
- Status last verified
- Dec 2024
- First submitted
- 23 Jun 2023
- Last updated
- 28 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Statistical programs in the data analysis will be written in R. The software and anonymized data will be included both as digital supplements in the published papers and will be posted on GitHub under github.com/StevenLShafer. Interested investigators will be able to reproduce the published analyses from these files. Consistent with the posting of software and data to the OpenTCI initiative, the software and de-identified data will be made available with "no strings attached," enabling investigators to freely use the data to inform or supplement additional research without restriction. Data to be made available are oxytocin dose, times of pharmacodynamic measures (relative to the start of dosing), simulated plasma oxytocin concentrations at those times for each subject, and age, weight, and sex for each subject.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining a Pharmacokinetic and Pharmacodynamic Model for Peripheral Analgesia After Intravenous Oxytocin
- ClinicalTrials.gov ID
- NCT05929339
- Acronym / sponsor ID
- IRB00097699
- Conditions
- Acute Pain, Chronic Pain, Healthy Volunteer
- Keywords
- Acute pain, Chronic Pain, Oxytocin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Posted 28 Oct 2025
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 clinical trial is to learn about oxytocin ( a naturally occurring hormone made in the brain that transmits messages) and the effects it may have on thermal heat pain after intravenous administration. The main question it aims to define is the time course of change in pain score after a 5 minute heating of the skin administered at intervals during and following infusion of intravenous oxytocin in order to create a Pharmacokinetic and a Pharmacodynamic model for oxytocin-induced analgesia.
Participants will be asked to rate thermal heat temperatures before, during and after the intravenous infusion of oxytocin.
Detailed description
The primary objective is to define the time course of change in pain score after a 5 minute heating of the skin applied at intervals during and following infusion of intravenous oxytocin in order to create a Pharmacokinetic and Pharmacodynamic model for oxytocin-induced analgesia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All subjects will receive two 30-minute infusions of oxytocin, 10 IU. The second infusion will be given 30 minutes after the completion of the first infusion. The first 8 subjects report pain at the end of 5 minutes of skin heating at intervals beginning 15 minutes after starting the first infusion. The remaining subjects will be randomized to report pain at the end of 5 minutes of skin heating at intervals beginning at either 10 or 20 minutes after starting the first infusion.
| Arm | Type | Receives |
|---|---|---|
| Verbal Pain Score at 10 Minutes | Other | Drug: OxytocinTwo 30 minute infusions of oxytocin, 10 IU, will be administered. The second infusion will be given 30 minutes after the completion of the first infusion. In this arm the first primary outcome measure (verbal pain report at the end of 5 minutes of skin heating) is obtained at 10 minutes after starting the intervention, then every 15 minutes until 115 minutes and at 180 minutes after starting the intervention. The primary outcome is also measured on separate study visits 24 hours and between 5-7 days after starting the first oxytocin infusion. |
| Verbal Pain Score at 15 Minutes | Other | Drug: OxytocinTwo 30 minute infusions of oxytocin, 10 IU, will be administered. The second infusion will be given 30 minutes after the completion of the first infusion. In this arm the first primary outcome measure (verbal pain report at the end of 5 minutes of skin heating) is obtained at 15 minutes after starting the intervention, then every 15 minutes until 120 minutes and at 180 minutes after starting the intervention. The primary outcome is also measured on separate study visits 24 hours and between 5-7 days after starting the first oxytocin infusion. |
| Verbal Pain Score at 20 Minutes | Other | Drug: OxytocinTwo 30 minute infusions of oxytocin, 10 IU, will be administered. The second infusion will be given 30 minutes after the completion of the first infusion. In this arm the first primary outcome measure (verbal pain report at the end of 5 minutes of skin heating) is obtained at 20 minutes after starting the intervention, then every 15 minutes until 125 minutes and at 180 minutes after starting the intervention. The primary outcome is also measured on separate study visits 24 hours and between 5-7 days after starting the first oxytocin infusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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, American Society of Anesthesiologists physical status 1, 2, or 3.
- For healthy volunteers, normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication. For knee arthritis subjects, normal blood pressure or, for those with hypertension, pressure controlled with anti-hypertensives and with a resting heart rate 45-100 beats per minute.
- Female subjects of child-bearing potential and those < 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.
Key exclusion criteria (8 listed)
- Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
- Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
- Women who are pregnant (positive result for serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years
- Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
- Subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval.
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 |
|---|---|---|
| OxytocinAlso: PitocinIntravenous oxytocin | Drug | Verbal Pain Score at 10 Minutes, Verbal Pain Score at 15 Minutes, Verbal Pain Score at 20 Minutes |
Primary outcome
Verbal Pain Score at the End of 5 Minutes of Skin Heating
Time frame: 5-7 days
Verbal pain score measured at one minute intervals during the 5 minute heating of the skin at intervals up to180 minutes after the initiation of the oxytocin infusions, then at 24 hours and 5-7 days after oxytocin infusions. The verbal pain score at the 5 minute measurement is the primary pharmacodynamic outcome for the purpose of modeling the pharmacokinetic-pharmacodynamic relationship. Note that the timing of the primary outcome differs among arms. Pain intensity report will be recorded each minute during the heating of the skin to 45 - 47 degrees Celsius . Pain will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Statistical programs in the data analysis will be written in R. The software and anonymized data will be included both as digital supplements in the published papers and will be posted on GitHub under github.com/StevenLShafer. Interested investigators will be able to reproduce the published analyses from these files. Consistent with the posting of software and data to the OpenTCI initiative, the software and de-identified data will be made available with "no strings attached," enabling investigators to freely use the data to inform or supplement additional research without restriction. Data to be made available are oxytocin dose, times of pharmacodynamic measures (relative to the start of dosing), simulated plasma oxytocin concentrations at those times for each subject, and age, weight, and sex for each subject.
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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
Wake Forest University Health Sciences
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 Oxytocin in people with Acute Pain and Chronic Pain, 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 4 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 28 Oct 2025. 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?
Yes. Results are posted in the registry (first posted 28 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Verbal Pain Score at the End of 5 Minutes of Skin Heating (time frame: 5-7 days). 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 28 Oct 2025.