Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30-75
SponsorYale University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Oxytocin (Low dose)
- Oxytocin (High dose)
- Placebo (saline)
Treatment groups
75 Participants
are divided into 3 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
Tonix Pharmaceuticals, Inc.
Collaborator
Source ClinicalTrials.gov