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

NCT07730294 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2000042469
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Pituitary Surgery

Keywords

pain; pain perception; oxytocin; intranasal

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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)

  Pre-op up to 8 weeks after last drug administration

• Changes in participant reported anxiety as measured by the Beck Anxiety Inventory (BAI)

  Pre-op up to 8 weeks after last drug administration

• Changes in participant reported anxiety as measured by the Generalized Anxiety Disorder-7

  Pre-op up to 8 weeks after last drug administration

• Changes in participant reported depression as measured by the Patient Health Questionnaire-9

  Pre-op up to 8 weeks after last drug administration

• Change in neural functioning measured by Electroencephalography (EEG)/Event-Related Potential (ERP)

  Pre-op and the last day of drug administration, approximately 14 days

Study Arms (3)

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.

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.

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.

Drug: Placebo (saline)

Interventions

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.

Low Dose Oxytocin

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.

High Dose Oxytocin

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.

Saline-Mg solution

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Tonix Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Oxytocin; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• S. Bulent Omay, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Helena Rutherford, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

S. Bulent Omay, MD

CONTACT

203-737-6885; sacit.omay@yale.edu

Helena Rutherford, PhD

CONTACT

helena.rutherford@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurosurgery and Otolaryngology

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 28, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)