Vasopressin Effects on Human Social Communication
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 30 |
| Updated: | 4/2/2016 |
| Start Date: | September 2011 |
| End Date: | July 2015 |
| Contact: | Debra D Burris, RN |
| Email: | burrid@mmc.org |
| Phone: | (207) 396-8240 |
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.
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.
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.
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.
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
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