A Phase 1 interventional study of Intranasal Oxytocin (IN-OXT) and Intranasal Oxytocin (IN-OXT) in Vasopressin Deficiency, sponsored by Elizabeth Austen Lawson. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Elizabeth Austen Lawson · Phase 1, Interventional, and Basic science
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:
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.
Exclusion Criteria:
Main visit 1: 6 IU intranasal oxytocin; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: intranasal placebo
Drug: Intranasal Oxytocin (IN-OXT) · Drug: Placebo
Main visit 1: 6 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 24 IU intranasal oxytocin
Drug: Intranasal Oxytocin (IN-OXT) · Drug: Placebo
Main visit 1: 24 IU intranasal oxytocin; Main visit 2: 6 IU intranasal oxytocin; Main visit 3: intranasal placebo
Drug: Intranasal Oxytocin (IN-OXT) · Drug: Placebo
Main visit 1: 24 IU intranasal oxytocin; Main visit 2: intranasal placebo; Main visit 3: 6 IU intranasal oxytocin
Drug: Intranasal Oxytocin (IN-OXT) · Drug: Placebo
Main visit 1: intranasal placebo; Main visit 2: 6 IU intranasal oxytocin; Main visit 3: 24 IU intranasal oxytocin
Drug: Intranasal Oxytocin (IN-OXT) · Drug: Placebo
Main visit 1: intranasal placebo; Main visit 2: 24 IU intranasal oxytocin; Main visit 3: 6 IU intranasal oxytocin
Drug: Intranasal Oxytocin (IN-OXT) · Drug: Placebo
Intranasal oxytocin 6 IU three times a day for 14 days
Drug: Intranasal Oxytocin (IN-OXT)
Intranasal placebo three times a day for 14 days
Drug: Placebo
6 IU single dose
IN-OXT 6 IU three times a day for 2 weeks
Intranasal placebo three times a day for 2 weeks
24 IU single dose
placebo single dose
Dot-probe task - anxious behavior between low dose oxytocin and placebo
Difference in response times (in milliseconds) to dots appearing in the location of the previously shown negative versus the neutral face between 6 IU oxytocin vs placebo in the dot-probe task.
Time frame: 20 minutes following intervention at each main visit
Dot-probe task - anxious behavior between all three interventions
Difference in response time (in milliseconds) to dots appearing in the location of the previously shown negative versus neutral face between 6 IU oxytocin, 24 IU oxytocin, and placebo in the dot-probe task.
Time frame: 20 minutes following intervention
Depressive behavior - probabilistic reward task between all three interventions
Response bias developed toward the more frequently reinforced alternative between 6 IU oxytocin, 24 IU oxytocin, and placebo in the probabilistic reward task.
Time frame: 30 minutes following intervention at each main visit
Socioemotional functioning - Emotion recognition task between all three interventions
Accuracy in identifying correct emotion between 6 IU oxytocin, 24 IU oxytocin, and placebo in the emotion recognition task.
Time frame: 40 minutes following intervention at each main visit
Plan to share: No
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Elizabeth Austen Lawson