Status:
RECRUITING
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Lead Sponsor:
Elizabeth Austen Lawson
Collaborating Sponsors:
Tonix Pharmaceuticals, Inc.
Conditions:
Vasopressin Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, placebo-controlled crossover pilot study of single-dose intranasal oxytocin (6 IU and 24 IU) vs. placebo in adult men and women (aged 18 years and above) with argin...
Eligibility Criteria
Inclusion
- Age 18 and above
- Arginine-vasopressin deficiency
- Normal FT4 or T4
- Normal serum/plasma sodium
- Stable hormone replacement
Exclusion
- Active substance use disorder within the last 6 months
- History of psychosis
- Suicidal behavior and/or active suicidal ideation with plan and/or intent, e.g., suicidal ideation of type 4 or type 5 as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS), in the last month
- Medication changes within 4 weeks of enrollment or planned medication changes during the study
- History of chronic nasal obstruction or local pathology in nostril pathway which, in the opinion of the investigator, would prevent appropriate nasal administration of the study drug.
- History of cardiac disease, including arrhythmias, coronary heart disease, coronary artery spasms, valvular heart disease, hypertrophic cardiomyopathy (hypertension is not exclusionary)
- History of chronic kidney disease stage III and above
- History of liver cirrhosis
- Pregnancy or breastfeeding within the last 8 weeks
- Unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only)
- Any significant illness, condition, drug or medical device that the Investigator determines could interfere with study participation, data collection, or safety
Key Trial Info
Start Date :
September 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04789148
Start Date
September 10 2025
End Date
June 1 2026
Last Update
September 16 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital, Neuroendocrine Unit
Boston, Massachusetts, United States, 02114