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NCT Number: NCT07730294

Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After 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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pituitary Surgery Signs and Symptoms

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale University

New Haven, Connecticut, 06510, United States

Location contact

Helena Rutherford, PhD

CONTACT

[email protected]

Helena Rutherford, PhD

PRINCIPAL_INVESTIGATOR

S. Bulent Omay, MD

CONTACT

[email protected]

203-737-6885

S. Bulent Omay, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Helena Rutherford, PhD

CONTACT

[email protected]

S. Bulent Omay, MD

CONTACT

[email protected]

203-737-6885

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Tonix Pharmaceuticals, Inc.

Registry information

Official study title

Investigating the Effect of TNX-1900 on Pain Management, Neural and Socio-Emotional Functioning in Patients Undergoing Pituitary Surgery

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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