Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery | NCT07730294

NCT07730294

Overview

NCT ID: NCT07730294
Lead Sponsor: Yale UniversityOTHER
Official Title: Investigating the Effect of TNX-1900 on Pain Management, Neural and Socio-Emotional Functioning in Patients Undergoing Pituitary Surgery
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
Interventions: Oxytocin (Low dose)

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 28, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Aug 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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 Plan

Study Type: Interventional
Phase: Phase 2
Enrollment: 75Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: S. Bulent Omay, MDContact
sacit.omay@yale.edu203-737-6885

Similar Studies

Participant Group/Arms

Low Dose OxytocinExperimental

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 OxytocinExperimental

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 solutionPlacebo 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)