Vasopressin Effects on Human Social Communication

Enrollment

225 participants (actual enrollment reported by the registry).

Study Design

Study Type

interventional

Phase

phase 1

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

PARTICIPANT, INVESTIGATOR

Masking Details

The Maine Medical Pharmacy prepared drug and placebo doses; when subjects were enrolled, the pharmacy randomly assigned the subject to a condition, and gave the unmarked nasal applicator to the subject, who was accompanied by the nurse/technician. Neither the subject nor the nurse/technician collecting data knw whether it was placebo or drug, nor which dose (20IU or 40IU) the subject would be receiving on the drug day.

Purpose

BASIC SCIENCE

Intervention Model

CROSSOVER

Model Details: In the work at Maine Medical, each subject received one of two doses of vasopressin (20IU or 40IU) on one test day, and placebo (sterile saline) on the other, in counterbalanced order. All subjects reported back for a 3rd day, 2-21 days after the 2nd test day, for a third test when no drug was administered. Because preliminary data analysis suggested the drug may have longer lasting, generalized effects on behavioral responses than anticipated, the second study done at Emory University with a single dose and in which subjects were also tested in fMRI, was changed to between-subjects design in which each subject either received placebo or 40IU on an initial test day and were then tested on a follow up test, 2-21 days later, when no drug was given.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Ph.D. Associated Professor

Study Record Dates