Investigating the Effect of TNX-1900 on Pain Management, Neural and Socio-Emotional Functioning in Patients Undergoing Pituitary Surgery
Yale University
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.
Description
This study employs a randomized, double-blind, placebo-controlled design to evaluate the efficacy of an intranasal oxytocin formulation, TNX-1900, on pain management, neural functioning, and socio-emotional health in patients undergoing pituitary surgery. Participants will be randomized into 3 groups: One group will receive low-dose oxytocin (6 IU), one group will receive high-dose oxytocin (24 IU), and one group will receive a matching placebo formulation. Participants will administer their nasal spray (blinded) daily for 7 days leading up to, and including the day of surgery, and 7 days foll…
Eligibility
- Age range
- 30–75 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugOxytocin (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.
- DrugOxytocin (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.
- DrugPlacebo (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.
Location
- Yale UniversityNew Haven, Connecticut