RECRUITING

Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 arginine-vasopressin deficiency to evaluate the effect of oxytocin on anxiety, depression, and socioemotional functioning (Part A), with an optional randomized, double-blind, placebo-controlled 2-week repeated dose substudy of intranasal oxytocin 6 IU or placebo (Part B). Following a screening visit to determine eligibility, participants will return for three main study visits in Part A. During the main study visits, study participants will receive either oxytocin or placebo, followed by assessments of emotional behavior. In Part A, thirty participants will be equally randomized to one of six possible groups: 1. 6 IU oxytocin - 24 IU oxytocin - placebo 2. 6 IU oxytocin - placebo - 24 IU oxytocin 3. 24 IU oxytocin - 6 IU oxytocin - placebo 4. 24 IU oxytocin - placebo - 6 IU oxytocin 5. placebo - 6 IU oxytocin - 24 IU oxytocin 6. placebo - 24 IU oxytocin - 6 IU oxytocin Following completion of the Part A crossover portion of the study, in Part B participants may also choose to continue participation in an optional, randomized, double-blind, placebo-controlled substudy of intranasal oxytocin 6 IU or placebo three times a day for two weeks, followed by assessments of emotional behavior.

Official Title

Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency - A Pilot Study

Quick Facts

Study Start:2025-09-10
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04789148

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 and above
  2. * Arginine-vasopressin deficiency
  3. * Normal FT4 or T4
  4. * Normal serum/plasma sodium
  5. * Stable hormone replacement
  1. * Active substance use disorder within the last 6 months
  2. * History of psychosis
  3. * 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
  4. * Medication changes within 4 weeks of enrollment or planned medication changes during the study
  5. * 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.
  6. * History of cardiac disease, including arrhythmias, coronary heart disease, coronary artery spasms, valvular heart disease, hypertrophic cardiomyopathy (hypertension is not exclusionary)
  7. * History of chronic kidney disease stage III and above
  8. * History of liver cirrhosis
  9. * Pregnancy or breastfeeding within the last 8 weeks
  10. * Unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only)
  11. * Any significant illness, condition, drug or medical device that the Investigator determines could interfere with study participation, data collection, or safety

Contacts and Locations

Study Contact

Francesca Galbiati, MD
CONTACT
(617) 726-3870
FGALBIATI@BWH.HARVARD.EDU
Elisa Asanza, MSN, MPH
CONTACT
617-726-3870
easanza@mgh.harvard.edu

Principal Investigator

Elizabeth A Lawson, MD, MMSc
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital, Neuroendocrine Unit
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Elizabeth Austen Lawson

  • Elizabeth A Lawson, MD, MMSc, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-10
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-09-10
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Hypopituitarism
  • posterior pituitary
  • oxytocin
  • psychopathology
  • anxiety
  • depressive symptoms
  • socioemotional functioning

Additional Relevant MeSH Terms

  • Vasopressin Deficiency