PainPhase 2NCT07730294
Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery
A Phase 2 study testing Oxytocin (Low dose) and Oxytocin (High dose) in people with Pain and Pituitary Surgery, run by Yale University at 1 site in United States.
Trial summary
This study is testing whether oxytocin can help lessen pain by changing how people process emotions and social experiences. The goal is to better understand how the brain links emotions, relationships, and pain, and whether this connection can be used to improve pain treatment. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Pain, Pituitary Surgery
- What is being tested?
- Oxytocin (Low dose) and Oxytocin (High dose)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2028
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Between 30 to 75 years old.
- Consent: Ability to give informed consent.
- Language: Proficiency in the English language.
- Medical Condition: Diagnosed with a pituitary lesion requiring surgery.
- Menopausal Status: Post-menopause for women (at least 1 year since last menstrual period).
Who cannot join
- Medication: Individuals on stable doses of psychotropic medication for at least the past six weeks are eligible, excluding those with changes in medication within that timeframe.
- Neurological Conditions: A history of seizures, current use of anticonvulsants.
- Pregnancy: Currently pregnant, currently lactating, or up to 1-year post partum.
- Any history of renal impairment (serum creatinine >1.2 x ULN)
- Any history of hepatic impairment (AST and/or ALT >2 x ULN)
- Surgical History: Any history of previous pituitary surgery procedures
- Subjects who require 24-hour coverage with NSAIDs, e.g., arthritis, should not be included in the study.
- Any known hypersensitivity to TNX-1900
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Helena Rutherford, PhD contact
United States1 site, 1 recruiting
- Recruiting
Yale University
New Haven, Connecticut, 06510
S. Bulent Omay, MD, 203-737-6885, sacit.omay@yale.edu
Helena Rutherford, PhD, helena.rutherford@yale.edu
About this study
Official title: Investigating the Effect of TNX-1900 on Pain Management, Neural and Socio-Emotional Functioning in Patients Undergoing Pituitary Surgery
This study is testing whether oxytocin can help lessen pain by changing how people process emotions and social experiences. The goal is to better understand how the brain links emotions, relationships, and pain, and whether this connection can be used to improve pain treatment.
Read the detailed description
This study employs a randomized, double-blind, placebo-controlled design to evaluate the efficacy of an intranasal oxytocin formulation, TNX-1900, on pain management, neural functioning, and socio-emotional health in patients undergoing pituitary surgery. Participants will be randomized into 3 groups: One group will receive low-dose oxytocin (6 IU), one group will receive high-dose oxytocin (24 IU), and one group will receive a matching placebo formulation. Participants will administer their nasal spray (blinded) daily for 7 days leading up to, and including the day of surgery, and 7 days following the surgery. Assessments (surveys and EEG/ERP) will be included throughout the protocol.
- Conditions
- Pain, Pituitary Surgery
- Being tested
- Oxytocin (Low dose), Oxytocin (High dose), Placebo (saline)
- Keywords
- pain, pain perception, oxytocin, intranasal
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin (Low dose)Drug
The dosage for low -dose intranasal oxytocin is set at 6 International Units (IU) per day, divided into two administrations of 3IU each per nostril. The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.
Oxytocin (High dose)Drug
The dosage for high-dose intranasal oxytocin is set at 24 International Units (IU) per day, divided into two administrations of 12 IU each per nostril. The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.
Placebo (saline)Drug
Placebo nasal spray (no study medication, magnesium only). The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Oxytocin | Experimental | Participants in this arm will receive low dose oxytocin beginning one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery. Receives: Drug: Oxytocin (Low dose) |
| High Dose Oxytocin | Experimental | Participants in this arm will receive high dose oxytocin beginning one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery. Receives: Drug: Oxytocin (High dose) |
| Saline-Mg solution | Placebo comparator | Participants in this arm will receive placebo beginning one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery. Receives: Drug: Placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in post-operative pain measured by the Numeric Pain Rating Scale (NPRS)
The NPRS is a patient-reported tool used to assess pain intensity on a scale from 0 (no pain) to 10 (worst possible pain).
Measured: Pre-op up to 8 weeks after last drug administration
Change in post-operative pain measured by monitoring of pain medication usage
Daily pain medication usage will be reported by participants leading up to surgery and after discharge. Daily pain medication usage will be reported through the participant's medical record during surgery and inpatient stay.
Measured: Pre-op up to 8 weeks after last drug administration
Secondary outcomes (5)
Changes in participant reported depression as measured by the Beck Depression Inventory (BDI-II)
BDI-II is a 21-item patient-reported questionnaire used to assess the severity of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating more severe depression.
Measured: Pre-op up to 8 weeks after last drug administration
Changes in participant reported anxiety as measured by the Beck Anxiety Inventory (BAI)
BAI is a 21-item patient-reported questionnaire used to assess the severity of anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating more severe anxiety.
Measured: Pre-op up to 8 weeks after last drug administration
Changes in participant reported anxiety as measured by the Generalized Anxiety Disorder-7
GAD-7 is a 7-item patient-reported questionnaire used to assess the severity of anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating more severe anxiety.
Measured: Pre-op up to 8 weeks after last drug administration
Changes in participant reported depression as measured by the Patient Health Questionnaire-9
PHQ-9 is a 9-item patient-reported questionnaire used to assess the severity of depressive symptoms. Total scores range from 0 to 27, with higher scores indicating more severe depression.
Measured: Pre-op up to 8 weeks after last drug administration
Change in neural functioning measured by Electroencephalography (EEG)/Event-Related Potential (ERP)
EEG/ERP sessions are done at specific intervals to look at delta-beta neural oscillations and N170, P300, and LPP ERPs elicited by social and emotional stimuli (photos of faces and houses).
Measured: Pre-op and the last day of drug administration, approximately 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Tonix Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Sacit Omay, Yale University
- Investigators
- S. Bulent Omay, MD, Principal investigator, Yale UniversityHelena Rutherford, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730294
- Sponsor's protocol ID
- 2000042469
- Status last verified
- Nov 2026
- First submitted
- 17 Jul 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share Individual Participant Data at this time.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of TNX-1900 on Pain Management, Neural and Socio-Emotional Functioning in Patients Undergoing Pituitary Surgery
- ClinicalTrials.gov ID
- NCT07730294
- Acronym / sponsor ID
- 2000042469
- Conditions
- Pain, Pituitary Surgery
- Keywords
- pain, pain perception, oxytocin, intranasal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Tonix Pharmaceuticals, Inc.
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 28 Jul 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.
This study is testing whether oxytocin can help lessen pain by changing how people process emotions and social experiences. The goal is to better understand how the brain links emotions, relationships, and pain, and whether this connection can be used to improve pain treatment.
Detailed description
This study employs a randomized, double-blind, placebo-controlled design to evaluate the efficacy of an intranasal oxytocin formulation, TNX-1900, on pain management, neural functioning, and socio-emotional health in patients undergoing pituitary surgery. Participants will be randomized into 3 groups: One group will receive low-dose oxytocin (6 IU), one group will receive high-dose oxytocin (24 IU), and one group will receive a matching placebo formulation. Participants will administer their nasal spray (blinded) daily for 7 days leading up to, and including the day of surgery, and 7 days following the surgery. Assessments (surveys and EEG/ERP) will be included throughout the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose Oxytocin | Experimental | Drug: Oxytocin (Low dose)Participants in this arm will receive low dose oxytocin beginning one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery. |
| High Dose Oxytocin | Experimental | Drug: Oxytocin (High dose)Participants in this arm will receive high dose oxytocin beginning one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery. |
| Saline-Mg solution | Placebo comparator | Drug: Placebo (saline)Participants in this arm will receive placebo beginning one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: Between 30 to 75 years old.
- Consent: Ability to give informed consent.
- Language: Proficiency in the English language.
- Medical Condition: Diagnosed with a pituitary lesion requiring surgery.
- Menopausal Status: Post-menopause for women (at least 1 year since last menstrual period).
Key exclusion criteria (8 listed)
- Medication: Individuals on stable doses of psychotropic medication for at least the past six weeks are eligible, excluding those with changes in medication within that timeframe.
- Neurological Conditions: A history of seizures, current use of anticonvulsants.
- Pregnancy: Currently pregnant, currently lactating, or up to 1-year post partum.
- Any history of renal impairment (serum creatinine >1.2 x ULN)
- Any history of hepatic impairment (AST and/or ALT >2 x ULN)
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 |
|---|---|---|
| Oxytocin (Low dose)The dosage for low -dose intranasal oxytocin is set at 6 International Units (IU) per day, divided into two administrations of 3IU each per nostril. The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery. | Drug | Low Dose Oxytocin |
| Oxytocin (High dose)The dosage for high-dose intranasal oxytocin is set at 24 International Units (IU) per day, divided into two administrations of 12 IU each per nostril. The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery. | Drug | High Dose Oxytocin |
| Placebo (saline)Placebo nasal spray (no study medication, magnesium only). The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery. | Drug | Saline-Mg solution |
Primary outcome
Change in post-operative pain measured by the Numeric Pain Rating Scale (NPRS)
Time frame: Pre-op up to 8 weeks after last drug administration
The NPRS is a patient-reported tool used to assess pain intensity on a scale from 0 (no pain) to 10 (worst possible pain).
Change in post-operative pain measured by monitoring of pain medication usage
Time frame: Pre-op up to 8 weeks after last drug administration
Daily pain medication usage will be reported by participants leading up to surgery and after discharge. Daily pain medication usage will be reported through the participant's medical record during surgery and inpatient stay.
5 secondary outcomes
Changes in participant reported depression as measured by the Beck Depression Inventory (BDI-II)
Time frame: Pre-op up to 8 weeks after last drug administration
Changes in participant reported anxiety as measured by the Beck Anxiety Inventory (BAI)
Time frame: Pre-op up to 8 weeks after last drug administration
Changes in participant reported anxiety as measured by the Generalized Anxiety Disorder-7
Time frame: Pre-op up to 8 weeks after last drug administration
Changes in participant reported depression as measured by the Patient Health Questionnaire-9
Time frame: Pre-op up to 8 weeks after last drug administration
Change in neural functioning measured by Electroencephalography (EEG)/Event-Related Potential (ERP)
Time frame: Pre-op and the last day of drug administration, approximately 14 days
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 6 Nov 2026.
- Individual participant dataSharing planned: No. There is no plan to share Individual Participant Data at this time.
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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.
Helena Rutherford, PhD contact
S. Bulent Omay, MD principal investigator
Yale University
Helena Rutherford, PhD principal investigator
Yale University
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 (Low dose) and Oxytocin (High dose) in people with Pain and Pituitary Surgery, run by Yale University 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 5 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: looking for participants now, as of the sponsor's last update on 6 Nov 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. 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 S. Bulent Omay, MD (203-737-6885, sacit.omay@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in post-operative pain measured by the Numeric Pain Rating Scale (NPRS) (time frame: Pre-op up to 8 weeks after last drug administration). 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 6 Nov 2026.