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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Oxytocin (Low dose)
DrugThe 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.
Oxytocin (High dose)
DrugThe 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.
Placebo (saline)
DrugPlacebo 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.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Low Dose OxytocinExperimental treatment 1 intervention
Group B: High Dose OxytocinExperimental treatment 1 intervention
Group C: Saline-Mg solutionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in post-operative pain measured by the Numeric Pain Rating Scale (NPRS)
The NPRS is a patient-reported tool used to assess pain intensity on a scale from 0 (no pain) to 10 (worst possible pain).
Time frame
Pre-op up to 8 weeks after last drug administration2
Change in post-operative pain measured by monitoring of pain medication usage
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.
Time frame
Pre-op up to 8 weeks after last drug administrationSecondary outcomes
1
Changes in participant reported depression as measured by the Beck Depression Inventory (BDI-II)
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.
Time frame
Pre-op up to 8 weeks after last drug administration2
Changes in participant reported anxiety as measured by the Beck Anxiety Inventory (BAI)
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.
Time frame
Pre-op up to 8 weeks after last drug administration3
Changes in participant reported anxiety as measured by the Generalized Anxiety Disorder-7
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.
Time frame
Pre-op up to 8 weeks after last drug administration4
Changes in participant reported depression as measured by the Patient Health Questionnaire-9
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.
Time frame
Pre-op up to 8 weeks after last drug administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Tonix Pharmaceuticals, Inc.
Collaborator
Source ClinicalTrials.gov
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