Overview
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 following the surgery. Assessments (surveys and EEG/ERP) will be included throughout the protocol.
Eligibility
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
