Intranasal oxytocin to help with pain after pituitary surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 2 trial, adults undergoing pituitary surgery are randomly assigned to low-dose oxytocin, high-dose oxytocin, or placebo for seven days before and after surgery. The study uses a double-blind design to compare pain outcomes, neural measures, and socio-emotional health across groups. Researchers will collect surveys and EEG/ERP data to understand how oxytocin might influence pain processing and emotional aspects of recovery. Safety and tolerability will be monitored throughout the perioperative period.

Why it matters

Who can join: the full rules

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

Where it's running

• Yale University
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: S. Bulent Omay, MD — Yale University
• Study coordinator: S. Bulent Omay, MD
• Email: sacit.omay@yale.edu
• Phone: 203-737-6885

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.