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

NCT07730294 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-07-28

No results posted yet for this study

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

Interventions

DRUG

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

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

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.

Sponsors & Collaborators

  • Tonix Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • S. Bulent Omay, MD · Yale University

  • Helena Rutherford, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-08-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07730294 on ClinicalTrials.gov