Vasopressin Effects on Human Social Communication (AVP)

November 1, 2017 updated by: Richmond R. Thompson, Bowdoin College

Phase 2 Study of Vasopressin Effects on Human Social Communication

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center, McGeachey Hall, OP Psych

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy men and women 21-30 years of age

Exclusion Criteria:

  • individuals with high blood pressure or a history of seizures
  • allergies
  • heart problems
  • psychiatric problems
  • drug abuse
  • pregnant All subjects will be given a preliminary medical and psychiatric exam as well as drug and (for women) pregnancy test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vasopressin, Arginine, ADH
We will test how vasopressin affects emotional responses to facial stimuli in healthy men and women.
Drug: Vasopressin, Arginine, ADH
Vasopressin will be dissolved in sterile saline and intranasally delivered in one of 2 doses to each subject (20IU, 40IU)
Other Names:
  • Arginine, ADH
Placebo Comparator: Sterile Salilne
Sterile saline will be administered intranasally and emotional responses to facial stimuli measured.
Drug: Placebo; Sterile Saline
Sterile saline will be delivered intranasally on a second test day, in counterbalanced order with vasopressin administration.
Other Names:
  • Sterile Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional Responses
Time Frame: 60 min
Physiological and behavioral measures of emotional responses to faces will be measured 30-60 min after the intranasal delivery of the drug. Specifically, electromyographic responses to same- and other-sex faces of two facial muscles, the corrugator supercilli and the zygomaticus major, will be recorded with surface electrodes, as will electrodermal skin conductance responses and heart rate accelerations. Additionally, subjects will be asked to rate how approachable each face is on a scale where -3 is threatening and not approachable and 3 is friendly and approachable.
60 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic contributions
Time Frame: 4 years
Emotional responses to vasopressin administration will be correlated with polymorphic variation in the gene for the V1a vasopressin receptor. Specifically, the magnitude of the responses discussed above will be correlated with the length of a polymorphic microsatellite region of the V1a promter.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bowdoin College

Collaborators

National Institute of Mental Health (NIMH)
MaineHealth

Investigators

  • Principal Investigator: Richmond Thompson, Ph.D., Bowdoin College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

March 30, 2011

First Submitted That Met QC Criteria

March 31, 2011

First Posted (Estimate)

April 1, 2011

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105,108
  • R01MH087721-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Vasopressin, Arginine, ADH

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe