HealthyPhase 1AVPNCT01327027
Vasopressin Effects on Human Social Communication
A Phase 1 study testing Vasopressin, Arginine, ADH in people with Healthy, run by Bowdoin College at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vasopressin, Arginine, ADH
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Apr 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women 21-30 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Maine Medical Center, McGeachey Hall, OP Psych
Portland, Maine, 04102
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Vasopressin, Arginine, ADH, Placebo; Sterile Saline
- Keywords
- vasopressin, antisocial, affiliation
- Medical subject headings
- Diabetes Insipidus, Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasopressin, Arginine, ADHDrug
Also called Arginine, ADH
Vasopressin will be dissolved in sterile saline and intranasally delivered in one of 2 doses to each subject (20IU, 40IU)
Placebo; Sterile SalineDrug
Also called Sterile Saline
Sterile saline will be delivered intranasally on a second test day, in counterbalanced order with vasopressin administration.
| Study group | Role | What they receive |
|---|---|---|
| Vasopressin, Arginine, ADH | Experimental | We will test how vasopressin affects emotional responses to facial stimuli in healthy men and women. Receives: Drug: Vasopressin, Arginine, ADH |
| Sterile Salilne | Placebo comparator | Sterile saline will be administered intranasally and emotional responses to facial stimuli measured. Receives: Drug: Placebo; Sterile Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional Responses
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.
Measured: 60 min
Secondary outcomes (1)
Genetic contributions
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2015
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bowdoin College
- Sponsor type
- University, hospital or other
- Collaborators
- MaineHealth, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Richmond R. Thompson, Bowdoin College
- Investigators
- Richmond Thompson, Ph.D., Principal investigator, Bowdoin College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327027
- Sponsor's protocol ID
- 105,108
- Other IDs
- R01MH087721-02
- Acronym
- AVP
- Status last verified
- Nov 2017
- First submitted
- 30 Mar 2011
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Price D, Burris D, Cloutier A, Thompson CB, Rilling JK, Thompson RR. Dose-Dependent and Lasting Influences of Intranasal Vasopressin on Face Processing in Men. Front Endocrinol (Lausanne). 2017 Sep 22;8:220. doi: 10.3389/fendo.2017.00220. eCollection 2017.
PubMed 29018407
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Vasopressin Effects on Human Social Communication
- ClinicalTrials.gov ID
- NCT01327027
- Acronym / sponsor ID
- AVP / 105,108
- Conditions
- Healthy
- Keywords
- vasopressin, antisocial, affiliation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Bowdoin CollegeUniversity, hospital or other
- Collaborators
- MaineHealth, National Institute of Mental Health (NIMH)
- Study start
- Sep 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 1 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vasopressin, Arginine, ADH | Experimental | Drug: Vasopressin, Arginine, ADHWe will test how vasopressin affects emotional responses to facial stimuli in healthy men and women. |
| Sterile Salilne | Placebo comparator | Drug: Placebo; Sterile SalineSterile saline will be administered intranasally and emotional responses to facial stimuli measured. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men and women 21-30 years of age
Key exclusion criteria (6 listed)
- individuals with high blood pressure or a history of seizures
- allergies
- heart problems
- psychiatric problems
- drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vasopressin, Arginine, ADHAlso: Arginine, ADHVasopressin will be dissolved in sterile saline and intranasally delivered in one of 2 doses to each subject (20IU, 40IU) | Drug | Vasopressin, Arginine, ADH |
| Placebo; Sterile SalineAlso: Sterile SalineSterile saline will be delivered intranasally on a second test day, in counterbalanced order with vasopressin administration. | Drug | Sterile Salilne |
Primary outcome
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.
1 secondary outcome
Genetic contributions
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Results publication: PubMed 29018407Price D, Burris D, Cloutier A, Thompson CB, Rilling JK, Thompson RR. Dose-Dependent and Lasting Influences of Intranasal Vasopressin on Face Processing in Men. Front Endocrinol (Lausanne). 2017 Sep 22;8:220. doi: 10.3389/fendo.2017.00220. eCollection 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richmond Thompson, Ph.D. principal investigator
Bowdoin College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vasopressin, Arginine, ADH in people with Healthy, run by Bowdoin College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional Responses (time frame: 60 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01327027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.