Pain, Pituitary Surgery
Conditions
Keywords
pain, pain perception, oxytocin, intranasal
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.
Detailed 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.
Interventions
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.
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.
Sponsors
Yale University
Tonix Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in post-operative pain measured by the Numeric Pain Rating Scale (NPRS) | Pre-op up to 8 weeks after last drug administration | The NPRS is a patient-reported tool used to assess pain intensity on a scale from 0 (no pain) to 10 (worst possible pain). |
| Change in post-operative pain measured by monitoring of pain medication usage | Pre-op up to 8 weeks after last drug administration | Daily pain medication usage will be reported by participants leading up to surgery and after discharge. Daily pain medication usage will be reported through the participant's medical record during surgery and inpatient stay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in participant reported depression as measured by the Beck Depression Inventory (BDI-II) | Pre-op up to 8 weeks after last drug administration | BDI-II is a 21-item patient-reported questionnaire used to assess the severity of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating more severe depression. |
| Changes in participant reported anxiety as measured by the Beck Anxiety Inventory (BAI) | Pre-op up to 8 weeks after last drug administration | BAI is a 21-item patient-reported questionnaire used to assess the severity of anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating more severe anxiety. |
| Changes in participant reported anxiety as measured by the Generalized Anxiety Disorder-7 | Pre-op up to 8 weeks after last drug administration | GAD-7 is a 7-item patient-reported questionnaire used to assess the severity of anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating more severe anxiety. |
| Changes in participant reported depression as measured by the Patient Health Questionnaire-9 | Pre-op up to 8 weeks after last drug administration | PHQ-9 is a 9-item patient-reported questionnaire used to assess the severity of depressive symptoms. Total scores range from 0 to 27, with higher scores indicating more severe depression. |
| Change in neural functioning measured by Electroencephalography (EEG)/Event-Related Potential (ERP) | Pre-op and the last day of drug administration, approximately 14 days | EEG/ERP sessions are done at specific intervals to look at delta-beta neural oscillations and N170, P300, and LPP ERPs elicited by social and emotional stimuli (photos of faces and houses). |
Countries
United States
Contacts
CONTACTS. Bulent Omay, MD
CONTACTHelena Rutherford, PhD
PRINCIPAL_INVESTIGATORS. Bulent Omay, MD
Yale University
PRINCIPAL_INVESTIGATORHelena Rutherford, PhD
Yale University
Outcome results
None listed