Recruiting
Phase 2

Oxytocin

Sponsor:

Yale University

Code:

NCT07730294

Conditions

Pain

Pituitary Surgery

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Oxytocin (Low dose)

Oxytocin (High dose)

Placebo (saline)

Study Details

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

Study ID

NCT07730294

Start date

Nov, 2026

Status verified date

Nov, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low Dose Oxytocin

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.

experimental: High Dose Oxytocin

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.

placebo comparator: Saline-Mg solution

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.

Interventions

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.

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.

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.

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 ]
  • Change in post-operative pain measured by monitoring of pain medication usage [ Time Frame: Pre-op up to 8 weeks after last drug administration ]

Central Contacts and Locations

Central contacts

S. Bulent Omay, MD

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

Helena Rutherford, PhD

helena.rutherford@yale.edu

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

S. Bulent Omay, MD

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

Helena Rutherford, PhD

helena.rutherford@yale.edu

Principal Investigator:

S. Bulent Omay, MD

More Information

Sponsor

Yale University

Last update posted

Nov 6, 2026

Last verified

Nov, 2026

Keywords

  • pain
  • pain perception
  • oxytocin
  • intranasal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-07. This information was provided to ClinicalTrials.gov by Yale University on 2026-11-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.