Acute PainPhase 2PAINOXYNCT07409753
Effects Of Intravenous Oxytocin On Peripheral Sensory Afferents Using Microneurography
A Phase 2 study testing Intravenous Oxytocin in people with Acute Pain, run by Wake Forest University Health Sciences at 1 site in Sweden.
Trial summary
The goal of this clinical trial is to learn if oxytocin reduces pain in a small area of skin after pulses of non-burning heat by changing how nerves in the heated area react to pressing a thin, bendable plastic bristle and a thick, non-bending plastic bristle in adult, healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- Intravenous Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 22 Oct 2025to 8 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In good health as determined by the Principal Investigator (PI) or co-investigators based on prior medical history, current psychiatric assessment, and clinical assessment of lab tests.
- Female participants of child-bearing potential including 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 abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.
- Normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication.
- Proficient in Swedish or English
Who cannot join
- Hypersensitivity, allergy, or a history of significant reaction to any ingredients of the active drug (Oxytocin Grindeks® 8.7 microgram/ml solution) or the placebo (Sodium Chloride , ATC code: V07AB).
- Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the PI, would place the participant at increased risk (active gynecologic disease in which increased uterine tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the participant's compliance with study procedures, or compromise the quality of the data.
- Women who are pregnant (positive result for urine pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years.
- Body Mass Index (BMI) > 30
- Participants with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
- Participants with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval.
Show all 10Show fewer
- Participants 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, antidepressants (SSRI's or MAOI), or the recreational drug ecstasy.
- Participants with a known latex allergy.
- Participants with substances use disorders or any other psychiatric disorder(s).
- Participant with high risk of fainting episodes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Linköping University
Linköping, 58183
Hakan Olausson, MD, PhD, +46 13286788, hakan.olausson@liu.se
Saad Nagi, PhD, +46 13286823, saad.nagi@liu.se
About this study
Official title: Examining The Effects Of Intravenous Oxytocin Infusion On Peripheral Sensory Afferents Using Microneurography Technique In Healthy Volunteers: A Triple-Blind, Randomized, Placebo-Controlled Trial
The goal of this clinical trial is to learn if oxytocin reduces pain in a small area of skin after pulses of non-burning heat by changing how nerves in the heated area react to pressing a thin, bendable plastic bristle and a thick, non-bending plastic bristle in adult, healthy participants. The man questions it aims to answer are:
Does oxytocin increase the number of times a fiber which normally responds only to the thin bristle fires (sends a signal) after the heat pulses.
Read more
Does oxytocin raise the number of times a fiber which normally responds only to the thick bristle fires (sends a signal) after the heat pulses.
Researchers will compare oxytocin to a placebo (a look-alike substance that contains no drug) to see if oxytocin ABC works to change how nerves react to light touch and painful pressing in an area of sensitized skin.
Participants will:
Receive an intravenous injection of oxytocin or placebo on one occasion On the same day, a needle will be put near nerve fibers to record their firing before and after a few cycles of short heating of the skin.
Read the detailed description
This protocol will utilize a randomized, triple-masked study design to compare intravenous (IV) oxytocin to placebo on peripheral nerve response to acute pain sensitization in healthy volunteers. Equal numbers of adult men and women; ages 18-65 will be recruited. Participants, recruited from the regional community will report to the Linköping University Neurophysiologic Research Laboratory (Linköping, Sweden) for a 2-hour visit to complete eligibility screening, informed consent, pregnancy and drug use laboratory tests, and questionnaires regarding drug and alcohol use, and receive training in the tests to be used on the study day.
On a subsequent study day, participants will come initially to the Linköping University Medical Center where an IV catheter will be inserted and they will receive either IV oxytocin (20 IU) or an equal volume of placebo. Study drug will be randomized and administered in two 30-minute infusions separated by the minutes. Rapid rates of oxytocin infusion can cause acute adverse events in the first minutes of infusion. Although these adverse events rapidly resolve despite continuing the infusion, one event (facial flushing) could negate the blind of study personnel. For that reason, the first infusion will be given at 2 rates, a very slow rate for the first 5 minutes and a greater rate for the remaining 25 minutes. This has been demonstrated to reduce the incidence of facial flushing with oxytocin to a rate similar to placebo. Participants will be continuously monitored for vital signs and intermittently queried for any subjective sensations or adverse events during infusion.
After study drug infusion is complete, the IV catheter will be removed and the participant accompanied to the Linköping University Neurophysiologic Research Laboratory, adjacent to the Medical Center, where they will complete psychologic questionnaires and cognitive tests and undergo sensory testing of the skin on the arm of brushing using a computer controlled, robotic system. Then, a 200 micrometer tungsten electrode will be inserted in the radial or peroneal nerve under real-time ultrasound guidance and manipulated until a single nerve fiber and its area of skin innervation (receptive field) are identified. The nerve fiber will be categorized by its speed of conduction and firing pattern to a variety of non-noxious and noxious sensory stimuli to the receptive field. A temperature controlled thermode will be placed on the skin adjacent to and overlapping with the receptive field and acute inflammation induced by 10-second cycles of heating the probe to 50°C with 10 seconds at a non-noxious temperature (30°C) between each heat pulse for a total of 2 minutes. The response of the nerve fiber to noxious and non-noxious stimuli will be repeated.
The primary analysis will compare fiber firing in response to a fixed intensity punctate stimulus in the fiber's receptive field between oxytocin and placebo and will be performed separately on touch-sensitive fibers (fast conducting, low threshold mechanoreceptors (A-LTMRs)) and pain-sensitive fibers (fast conducting, low threshold mechanoreceptors (A-HTMRs)).
Based on numerous studies performed in rodents at Wake Forest University School of Medicine, we hypothesize that acute heat-induced inflammation will render A-LTMRs less responsive to a touch punctate stimulus and A-HTMRs more responsive to a noxious punctate stimulus and that both of these effects will be reduced by at least 50% in participants who receive IV oxytocin. If such results are obtained, they will challenge the existing paradigm that reduction in pain threshold (allodynia) after sensitization from peripheral injury is driven by increased A-LTMR input and support further exploration for the mechanisms by which oxytocin returns changes in touch and pain fibers towards normal to treat pain.
- Conditions
- Acute Pain
- Being tested
- Intravenous Oxytocin, Intravenous 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 Oxytocin-Grindeks
Intravenous oxytocin, 20 IU will be administered via two 30-minute infusions separated by 30 minutes
Intravenous PlaceboDrug
Also called Saline
Intravenous placebo will be infused in the same volume and timing as the intravenous oxytocin intervention
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Oxytocin | Experimental | 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. Receives: Drug: Intravenous Oxytocin |
| Intravenous Placebo | Placebo comparator | 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. Receives: Drug: Intravenous Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of nerve fiber discharges with von Frey filament application
The number of nerve fiber discharges in response to a 5 second application of a 20 mN force von Frey filament and to a 1000 mN force von Frey filament to the area of skin responding to sensory stimulation. These are measured twice, once before and once after skin inflammation induced by heat pulses.
Measured: 2-8 hours after start of the first IV infusion
Secondary outcomes (7)
Verbal pain intensity score with von Frey filament application
Verbal pain intensity score in response to a 5 second application of a 20 mN force von Frey filament and to a 1000 mN force von Frey filament to the area of skin responding to sensory stimulation. Pain scores are obtained twice, once before and once after skin inflammation induced by heat pulses. Pain intensity is rated on a 0-10 scale with 0 being no pain at all and 10 being the worst imaginable pain.
Measured: 2-8 hours after start of the first IV infusion
Pattern of nerve fiber discharges with von Frey filament application
The pattern of spikes in response to a 5 second application of 20 mN force von Frey filament and to a 1000 mN force von Frey filament to the area of skin responding to sensory stimulation. Pattern is categorized as one of 4 choices (rapidly adapting, slow adapting, continuous, or on-off) according to standard neurophysiological definitions. These will be measured twice, once before and once after heat-induced inflammation
Measured: 2-8 hours after start of the first IV infusion
Number of nerve fiber burst discharges with tuning fork application
The number of spike bursts in response to a 2 second application of a 128 Hz tuning fork to the receptive field. If there are any bursts to 128 Hz, then the test will be repeated with, separately, a 75 Hz tuning fork and a 512 Hz tuning fork to the area of skin responding to sensory stimulation. Spike bursts are defined as multiple spikes coinciding with each vibration of the tuning fork. These will be measured twice, once before and once after heat-induced inflammation
Measured: 2-8 hours after start of the first IV infusion
Number of nerve fiber discharges with warming and cooling
The number of discharges in response to slow warming to 50 degrees C and slow cooling to 0 degrees C by application of a Peltier-controlled thermode to the area of skin responding to sensory stimulation. Spike bursts are defined as multiple spikes coinciding with each vibration of the tuning fork. These will be measured twice, once before and once after heat-induced inflammation
Measured: 2-8 hours after start of the first IV infusion
Number of nerve fiber discharges with soft brushing
The number of discharges in response to brushing in the receptive field using a computer controlled robotic device at various pressures and speeds. Total discharges with each brush will be measured. The brushing tests will be performed twice, once before and once after heat-induced inflammation
Measured: 2-8 hours after start of the first IV infusion
Number of nerve fiber discharges with von Frey filament application: stimulus response relationship
The number of discharges in response to 5 sec application of von Frey filaments of 8 different forces from 4-3000 mN, presented in random order to the area of skin responding to sensory stimulation. Threshold will be determined as the lowest force resulting in any discharge. A stimulus response curve will be created using number of discharges to 5 second von Frey application at each of the 8 forces. This stimulus response is measured twice, once before and once after skin inflammation induced by heat pulses.
Measured: 2-8 hours after start of the first IV infusion
Inflammation response to skin heating
The area of erythema immediately after skin heating to 6 cycles of 50 degrees C for 10 sec over a total of 2 minutes will be calculated by measurement of height and width in mm, with values expressed in mm squared.
Measured: 2-8 hours after start of the first IV infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start22 Oct 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion8 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Each participant will be randomized to receive an intravenous (IV) infusion of study drug, either IV saline (placebo) or IV oxytocin (20 IU).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Eisenach, MD, Study chair, Atrium Health Wake Forest University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409753
- Sponsor's protocol ID
- P01-119159 Microneur. Study
- Other IDs
- P01NS119159, 2024-519670-39-00
- Acronym
- PAINOXY
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be anonymized and summarized in publications.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining The Effects Of Intravenous Oxytocin Infusion On Peripheral Sensory Afferents Using Microneurography Technique In Healthy Volunteers: A Triple-Blind, Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07409753
- Acronym / sponsor ID
- PAINOXY / P01-119159 Microneur. Study
- Conditions
- Acute Pain
- Keywords
- healthy volunteers, pain control, oxytocin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Linkoeping University
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 8 Jun 2027 (estimated)
- First posted
- 13 Feb 2026 (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 clinical trial is to learn if oxytocin reduces pain in a small area of skin after pulses of non-burning heat by changing how nerves in the heated area react to pressing a thin, bendable plastic bristle and a thick, non-bending plastic bristle in adult, healthy participants. The man questions it aims to answer are:
Does oxytocin increase the number of times a fiber which normally responds only to the thin bristle fires (sends a signal) after the heat pulses.
Does oxytocin raise the number of times a fiber which normally responds only to the thick bristle fires (sends a signal) after the heat pulses.
Researchers will compare oxytocin to a placebo (a look-alike substance that contains no drug) to see if oxytocin ABC works to change how nerves react to light touch and painful pressing in an area of sensitized skin.
Participants will:
Receive an intravenous injection of oxytocin or placebo on one occasion On the same day, a needle will be put near nerve fibers to record their firing before and after a few cycles of short heating of the skin.
Detailed description
This protocol will utilize a randomized, triple-masked study design to compare intravenous (IV) oxytocin to placebo on peripheral nerve response to acute pain sensitization in healthy volunteers. Equal numbers of adult men and women; ages 18-65 will be recruited. Participants, recruited from the regional community will report to the Linköping University Neurophysiologic Research Laboratory (Linköping, Sweden) for a 2-hour visit to complete eligibility screening, informed consent, pregnancy and drug use laboratory tests, and questionnaires regarding drug and alcohol use, and receive training in the tests to be used on the study day.
On a subsequent study day, participants will come initially to the Linköping University Medical Center where an IV catheter will be inserted and they will receive either IV oxytocin (20 IU) or an equal volume of placebo. Study drug will be randomized and administered in two 30-minute infusions separated by the minutes. Rapid rates of oxytocin infusion can cause acute adverse events in the first minutes of infusion. Although these adverse events rapidly resolve despite continuing the infusion, one event (facial flushing) could negate the blind of study personnel. For that reason, the first infusion will be given at 2 rates, a very slow rate for the first 5 minutes and a greater rate for the remaining 25 minutes. This has been demonstrated to reduce the incidence of facial flushing with oxytocin to a rate similar to placebo. Participants will be continuously monitored for vital signs and intermittently queried for any subjective sensations or adverse events during infusion.
After study drug infusion is complete, the IV catheter will be removed and the participant accompanied to the Linköping University Neurophysiologic Research Laboratory, adjacent to the Medical Center, where they will complete psychologic questionnaires and cognitive tests and undergo sensory testing of the skin on the arm of brushing using a computer controlled, robotic system. Then, a 200 micrometer tungsten electrode will be inserted in the radial or peroneal nerve under real-time ultrasound guidance and manipulated until a single nerve fiber and its area of skin innervation (receptive field) are identified. The nerve fiber will be categorized by its speed of conduction and firing pattern to a variety of non-noxious and noxious sensory stimuli to the receptive field. A temperature controlled thermode will be placed on the skin adjacent to and overlapping with the receptive field and acute inflammation induced by 10-second cycles of heating the probe to 50°C with 10 seconds at a non-noxious temperature (30°C) between each heat pulse for a total of 2 minutes. The response of the nerve fiber to noxious and non-noxious stimuli will be repeated.
The primary analysis will compare fiber firing in response to a fixed intensity punctate stimulus in the fiber's receptive field between oxytocin and placebo and will be performed separately on touch-sensitive fibers (fast conducting, low threshold mechanoreceptors (A-LTMRs)) and pain-sensitive fibers (fast conducting, low threshold mechanoreceptors (A-HTMRs)).
Based on numerous studies performed in rodents at Wake Forest University School of Medicine, we hypothesize that acute heat-induced inflammation will render A-LTMRs less responsive to a touch punctate stimulus and A-HTMRs more responsive to a noxious punctate stimulus and that both of these effects will be reduced by at least 50% in participants who receive IV oxytocin. If such results are obtained, they will challenge the existing paradigm that reduction in pain threshold (allodynia) after sensitization from peripheral injury is driven by increased A-LTMR input and support further exploration for the mechanisms by which oxytocin returns changes in touch and pain fibers towards normal to treat pain.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant will be randomized to receive an intravenous (IV) infusion of study drug, either IV saline (placebo) or IV oxytocin (20 IU).
| Arm | Type | Receives |
|---|---|---|
| Intravenous Oxytocin | Experimental | Drug: Intravenous OxytocinOxytocin, 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 | Placebo comparator | Drug: Intravenous PlaceboSaline 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In good health as determined by the Principal Investigator (PI) or co-investigators based on prior medical history, current psychiatric assessment, and clinical assessment of lab tests.
- Female participants of child-bearing potential including 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 abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.
- Normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication.
- Proficient in Swedish or English
Key exclusion criteria (10 listed)
- Hypersensitivity, allergy, or a history of significant reaction to any ingredients of the active drug (Oxytocin Grindeks® 8.7 microgram/ml solution) or the placebo (Sodium Chloride , ATC code: V07AB).
- Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the PI, would place the participant at increased risk (active gynecologic disease in which increased uterine tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the participant's compliance with study procedures, or compromise the quality of the data.
- Women who are pregnant (positive result for urine pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years.
- Body Mass Index (BMI) > 30
- Participants with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
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: Oxytocin-GrindeksIntravenous oxytocin, 20 IU will be administered via two 30-minute infusions separated by 30 minutes | Drug | Intravenous Oxytocin |
| Intravenous PlaceboAlso: SalineIntravenous placebo will be infused in the same volume and timing as the intravenous oxytocin intervention | Drug | Intravenous Placebo |
Primary outcome
Number of nerve fiber discharges with von Frey filament application
Time frame: 2-8 hours after start of the first IV infusion
The number of nerve fiber discharges in response to a 5 second application of a 20 mN force von Frey filament and to a 1000 mN force von Frey filament to the area of skin responding to sensory stimulation. These are measured twice, once before and once after skin inflammation induced by heat pulses.
7 secondary outcomes
Verbal pain intensity score with von Frey filament application
Time frame: 2-8 hours after start of the first IV infusion
Pattern of nerve fiber discharges with von Frey filament application
Time frame: 2-8 hours after start of the first IV infusion
Number of nerve fiber burst discharges with tuning fork application
Time frame: 2-8 hours after start of the first IV infusion
Number of nerve fiber discharges with warming and cooling
Time frame: 2-8 hours after start of the first IV infusion
Number of nerve fiber discharges with soft brushing
Time frame: 2-8 hours after start of the first IV infusion
Number of nerve fiber discharges with von Frey filament application: stimulus response relationship
Time frame: 2-8 hours after start of the first IV infusion
Inflammation response to skin heating
Time frame: 2-8 hours after start of the first IV infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No. Data will be anonymized and summarized in publications.
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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.
James Eisenach, MD study chair
Atrium Health Wake Forest University School of Medicine
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 in people with Acute Pain, run by Wake Forest University Health Sciences at 1 site in Sweden.
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 10 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: looking for participants now, as of the sponsor's last update on 13 Feb 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hakan Olausson, MD, PhD (+46 13286788, hakan.olausson@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of nerve fiber discharges with von Frey filament application (time frame: 2-8 hours after start of the first IV infusion). 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 13 Feb 2026.