Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oxytocin (Low dose), Oxytocin (High dose), Placebo (saline).
- Who it may be relevant to
- Registry conditions: Pain, Pituitary Surgery. Basic parameters: 30 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigating the Effect of TNX-1900 on Pain Management, Neural and Socio-Emotional Functioning in Patients Undergoing Pituitary Surgery
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.
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
- Drug Oxytocin (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. - Drug Oxytocin (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. - Drug Placebo (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.
Primary outcome measures
- Change in post-operative pain measured by the Numeric Pain Rating Scale (NPRS) [Time frame: Pre-op up to 8 weeks after last drug administration]
- Change in post-operative pain measured by monitoring of pain medication usage [Time frame: Pre-op up to 8 weeks after last drug administration]
Secondary outcome measures (5)
- Changes in participant reported depression as measured by the Beck Depression Inventory (BDI-II) [Time frame: Pre-op up to 8 weeks after last drug administration]
- Changes in participant reported anxiety as measured by the Beck Anxiety Inventory (BAI) [Time frame: Pre-op up to 8 weeks after last drug administration]
- Changes in participant reported anxiety as measured by the Generalized Anxiety Disorder-7 [Time frame: Pre-op up to 8 weeks after last drug administration]
- Changes in participant reported depression as measured by the Patient Health Questionnaire-9 [Time frame: Pre-op up to 8 weeks after last drug administration]
- Change in neural functioning measured by Electroencephalography (EEG)/Event-Related Potential (ERP) [Time frame: Pre-op and the last day of drug administration, approximately 14 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Yale University — New Haven
Identifiers
NCT: NCT07730294 · 2000042469