What this study is
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.
What's being tested
- Oxytocin (Low dose)
Intervention · 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.
- Oxytocin (High dose)
Intervention · 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.
- Placebo (saline)
Intervention · 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.
Study details
- Official title
- Investigating the Effect of TNX-1900 on Pain Management, Neural and Socio-Emotional Functioning in Patients Undergoing Pituitary Surgery
- Sponsor
- Yale University
- Conditions
- Pain · Pituitary Surgery
- Enrolling
- 75 people
- Starts
- 2026-11
- Est. completion
- 2028-11
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 30 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openYale University
New Haven, Connecticut, United States
- S. Bulent Omay, MD · Contact203-737-6885sacit.omay@yale.edu
- Helena Rutherford, PhD · Contacthelena.rutherford@yale.edu
- S. Bulent Omay, MD · Principal investigator
- Helena Rutherford, PhD · Principal investigator
Recruiting
Study team
Sponsor
Yale University
Study ID 2000042469
Principal investigator
S. Bulent Omay, MD
Yale University
Principal investigator
Helena Rutherford, PhD
Yale University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.