Vasopressin Effects on Human Social Communication
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This research is being done because we wish to understand how a chemical produced in the
      brain, vasopressin, effects emotional social communication processes. Understanding how this
      system works in normal individuals may help us understand why some people, particularly those
      with autism and/or antisocial personality disorder, have dysfunctional social interactions.

      This study will test the effects of 3 doses of arginine vasopressin, delivered intranasally,
      on physiological and behavioral responses to the faces of same- and other-sex individuals in
      healthy men and women.
    

Detailed description: 
      If you decide to participate you will sign this informed consent and Dr. Price will ask you
      questions about your medications, medical history, and how you are feeling on that particular
      day. You will be asked to complete a questionnaire regarding Childhood Trauma and a Brief
      Psychiatric Rating Scale. You will undergo a brief physical examination which includes an EKG
      (to look at your heart function), blood pressure and pulse by Dr. Daniel Price at the Maine
      Medical Center. You will also be asked to provide a urine sample for drug testing and, if you
      are a female, for pregnancy testing. Individuals with any positive results or results which
      indicate a need for medical intervention will be confidentially informed by Dr. Price and
      will not be allowed to participate in this study. Dr. Price will facilitate the transition to
      medical personnel if needed. Only Dr. Price will be aware of the results from the drug and
      pregnancy tests, and those results will not be shared with any other members of the research
      team, Bowdoin administrative officials, law enforcement officers, parents or anybody else.

      If you meet the criteria for entry and agree to proceed you will be asked to submit a blood
      sample so we can analyze the DNA in one of your genes. All results from these tests will be
      kept strictly confidential and protected with a National Institutes of Mental Health
      confidentiality certificate. You will be required to report back to Maine Medical Center on
      three additional days which are one to two days apart. At visit one you will be randomized to
      receive one of two substances which you will self administer via a spray into your nose. You
      will self administer the nasal spray at visit one and visit two only. Visit three will not
      include the administration of the nasal spray. Neither you nor the person administering the
      testing will be aware if the nasal spray is vasopressin dissolved in sterile saline or
      sterile saline alone. The nasal spray will be in an applicator which will be provided to you
      upon your arrival at each study treatment visit. You will be instructed on how to use the
      nasal sprayer by a member of the study team.

      At the start of each of the three study visits, surface skin electrodes will be attached to
      your palms and forearms to measure skin conductance and heart rate, respectively, and to your
      face to record muscle activity in your facial muscles. You will then be asked to view a
      series of facial images while baseline physiological measures are recorded. On the first and
      second visits 30 minutes following the self administration of the nasal spray, you will view
      another series of images and answer questions and a 5 ml (approximately one teaspoon) blood
      sample will be taken from your vein.

      On the first and second visit days (when you receive the nasal spray) you will be advised to
      drink no more than 1 glass of fluid (approx. 8 oz) to prevent excess water retention in
      response to AVP, and refrain from caffeine consumption two hours before coming to the
      experiment. On each return visit you will be asked about any medications you may have taken
      since the last visit. If you have taken any new prescription medication or recreational
      substances you will not be able to proceed with the study. You will have your blood pressure
      and temperature measured at baseline, before administration of study drug (pre-dose), again
      at 5 minutes after study drug administration (post-dose), 20 minutes post dose and 60 minutes
      post dose. Although it is unlikely, if there are any changes in your blood pressure or body
      temperature Dr. Price will facilitate the need for any medical attention. If you are feeling
      well and there are no changes in your blood pressure, pulse or body temperature, you will be
      able to leave approximately one hour after study drug administration.

      Each of the three subsequent visits will last approximately two hours.
    

Intervention name(s): Vasopressin, Arginine, ADH; Placebo; Sterile Saline
Intervention type(s): Drug; Drug
Intervention description(s): Vasopressin will be dissolved in sterile saline and intranasally delivered in one of 2 doses to each subject (20IU, 40IU); Sterile saline will be delivered intranasally on a second test day, in counterbalanced order with vasopressin administration.
Other intervention name(s): Arginine, ADH; Sterile Saline
Intervention MeSH terms: Vasopressins; Arginine Vasopressin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 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.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: vasopressin; antisocial; affiliation