Social PsychologyEarly Phase 1NCT02394054
Vasopressin and the Social Brain
A Early Phase 1 study testing Intranasal vasopressin in people with Social Psychology, run by University of California, Los Angeles at 1 site in United States.
Trial summary
It has long been established that interpersonal relationships can have a profound impact on health and well-being. Yet, the investigators are still learning about the complex biological processes that contribute to positive social interactions and the ability to develop and maintain social relationships. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Psychology
- What is being tested?
- Intranasal vasopressin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jul 2016
- Phase
- Early 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
- 18-30 years of age
- Healthy (see below)
- Fluent in English
- Right-handed
Who cannot join
- Women who gave birth in the last six months, are currently pregnant, planning to become pregnant in the next 6 months, or currently breastfeeding women
- Symptoms of runny nose due to allergies/cold or other reason
- Current restricted fluid intake for any reason
- Heart disease
- Hypertension
- History of myocardial infarction
Show all 31Show fewer
- History of cardiac arrhythmia
- Kidney or liver disease
- Vascular disease
- Epilepsy
- Migraine
- Asthma
- Nephritis
- Diabetes and other endocrine diseases
- Frequent or unexplained fainting
- History of stroke
- Aneurysm or brain hemorrhage
- Active psychiatric diagnosis
- Current psychopharmacologic treatment
- Drug or alcohol abuse
- Medical or neurological illness
- Regular use of medication (e.g., vasoconstrictive medications)
- Medication intake less than 2 weeks prior to study (5 weeks for fluoxetine) including daily non-steroidal anti-inflammatory drugs
- Smoking more than 15 cigarettes a day
- Consumption of any alcoholic beverages in the past 24 hours will be excluded
- Elevated blood pressure (>135/90)
- Low blood pressure (<90/55)
- Body temperature >100.1 F
- Left-handed
- Claustrophobia
- Presence of metal in their body
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Department of Psychology
Los Angeles, California, 90095-1563
About this study
Official title: Vasopressin's Effect on Behavior and Neural Activity During Social Cognition Tasks
It has long been established that interpersonal relationships can have a profound impact on health and well-being. Yet, the investigators are still learning about the complex biological processes that contribute to positive social interactions and the ability to develop and maintain social relationships. Recent research has begun to focus on vasopressin, a neuropeptide that is naturally produced in the hypothalamus, because administration of this neuropeptide has been associated with empathy, cooperation, memory of social stimuli (e.g., faces), and brain activity in neural regions associated with social and emotional processes. To date, several aspects of vasopressin's effects on social behavior have been unexplored. As such, the overarching goal of this project is to examine the effects of intranasal vasopressin on several tasks involving learning and social processes. In addition, the investigators will explore associated neural activity through functional magnetic resonance imaging (fMRI). Results from the study will inform our understanding of the neurobiology of socioemotional processes.
The investigators hypothesize that compared to placebo, vasopressin will improve deception detection, increase empathy and altruism, enhance responses to photo stimuli of primary caregivers, and improve learning when the subject has a prosocial goal of teaching another person. These effects will manifest in behavioral and neural activity. It is also hypothesized that main effects will not be found for vasopressin, but rather, analyses of relevant moderators will elucidate these findings.
- Conditions
- Social Psychology
- Being tested
- Intranasal vasopressin, Intranasal placebo
- Keywords
- vasopressin, intranasal administration, healthy sample
- Medical subject headings
- Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal vasopressinDrug
Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).
Intranasal placeboDrug
Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: 2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal vasopressin | Experimental | Participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin). Receives: Drug: Intranasal vasopressin |
| Intranasal placebo | Placebo comparator | 2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter. Participants will self-administer 5 puffs per nostril. Receives: Drug: Intranasal placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in neural brain activity, as observed by fMRI, when observing others during social inclusion vs. exclusion
Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the vasopressin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater during the exclusion portion of the cyberball task (Williams et al., 2012) versus the inclusion portion. A first-level analysis will compare [(friend exclusion>friend inclusion)>(stranger exclusion>stranger inclusion)] for each participant. A second-level group analysis will compare these first-level contrasts between the vasopressin and placebo groups.
Measured: Between 40-115 minutes post administration
Secondary outcomes (7)
Ratings of empathic concern after witnessing social exclusion in a friend or a stranger
Ratings of empathic concern will be calculated for each participant by deriving a composite from self-report ratings of sympathy and compassion. Using a mixed 2 (friend, stranger) x 2 (vasopressin, placebo) factorial design, comparisons of these ratings will then be made for those in the vasopressin vs. placebo groups. Main effects of drug condition (vasopressin, placebo) as well as the interaction between drug condition and target (friend, stranger) will be analyzed at a significance level of p<.05.
Measured: Between 40-115 minutes post administration
Altruism and punishment as measured by number of points given to excluders and those excluded
Ratings of altruism and punishment will be calculated by examining how many point (1-10) participants decide to allocate towards the friend-excluder, stranger-excluder, excluded friend, and excluded stranger after watching each social exclusion game. Using a mixed 2 (friend, stranger) x 2 (vasopressin, placebo) factorial design, comparisons of these ratings will then be made for those in the vasopressin vs. placebo groups. Main effects of drug condition (vasopressin, placebo) and target (friend, stranger), as well as an interaction between drug condition and target will be analyzed at a significance level of p<.05.
Measured: Between 40-115 minutes post administration
Changes in neural brain activity, as observed by fMRI, while attempting to detect deception
Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the vasopressin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater during the deception detection task versus a control task. A first-level analysis will compare deception-detection>control for each participant. A second-level group analysis will compare this first-level contrast between the vasopressin and placebo groups.
Measured: Between 40-115 minutes post administration
Accuracy of deception detection as measured by self-report
The investigators will compare the percentage of correct deception detection trials for participants in the vasopressin group to those in the placebo group by running a two-tailed t-test with a statistical cutoff of p<.05 to determine significance.
Measured: Between 40-115 minutes post administration
Changes in neural brain activity, as observed by fMRI, when viewing images of primary caregivers versus strangers
Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the vasopressin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater while viewing photo stimuli of ones primary caregivers versus viewing photo stimuli of matched strangers. A first-level analysis will compare primary-caregiver-viewing>stranger-viewing for each participant. A second-level group analysis will compare this first-level contrast between the vasopressin and placebo groups.
Measured: Between 40-115 minutes post administration
Changes in brain neural activity, observed by fMRI, in response to a reading comprehension task
Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the tutor/memorizer and vasopressin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater during reading comprehension compared with the grammar control passage. First level analyses will compare the response during the reading comprehension passages relative to the grammar control passages. Second level group analyses will compare the first level contrasts between the tutor vs. memorizer groups as well as the vasopressin vs. placebo groups. In regression analyses the investigators will enter each participant's comprehension test score in the tutor and then memorizer condition as a regressor in a whole-brain and ROI analysis to determine which brain regions were more active during the encoding of the reading comprehension passage compared to the grammar control passage.
Measured: Between 40-90 minutes post administration
Performance on a memory test of reading comprehension as measured by percentage of questions answered correctly
Accuracy will be calculated for each participant by dividing the number of correct responses by the total number of questions. The investigators will then conduct a between-subjects 2x2 ANOVA on the accuracy scores for the four groups of interest (i.e., vasopressin-tutor, vasopressin-memorizer, placebo-tutor, placebo-memorizer). A significance level of p<.05 will be used to determine whether there are significant differences between the groups. The investigators will examine whether there is a main effect of either factor (vasopressin vs. placebo, tutor vs. memorize) as well as an interaction between the factors of interest.
Measured: Between 40-90 minutes post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2016
- Study completionJul 2016
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 Social PsychologyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Lieberman, University of California, Los Angeles
- Investigators
- Matthew D Lieberman, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394054
- Sponsor's protocol ID
- 11-003565-3
- Status last verified
- Aug 2017
- First submitted
- 22 Jan 2015
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Straccia MA, Teed AR, Katzman PL, Tan KM, Parrish MH, Irwin MR, Eisenberger NI, Lieberman MD, Tabak BA. Null results of oxytocin and vasopressin administration on mentalizing in a large fMRI sample: evidence from a randomized controlled trial. Psychol Med. 2023 Apr;53(6):2285-2295. doi: 10.1017/S0033291721004104. Epub 2021 Oct 15.
PubMed 37310308
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasopressin's Effect on Behavior and Neural Activity During Social Cognition Tasks
- ClinicalTrials.gov ID
- NCT02394054
- Acronym / sponsor ID
- 11-003565-3
- Conditions
- Social Psychology
- Keywords
- vasopressin, intranasal administration, healthy sample
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Mar 2015 (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.
It has long been established that interpersonal relationships can have a profound impact on health and well-being. Yet, the investigators are still learning about the complex biological processes that contribute to positive social interactions and the ability to develop and maintain social relationships. Recent research has begun to focus on vasopressin, a neuropeptide that is naturally produced in the hypothalamus, because administration of this neuropeptide has been associated with empathy, cooperation, memory of social stimuli (e.g., faces), and brain activity in neural regions associated with social and emotional processes. To date, several aspects of vasopressin's effects on social behavior have been unexplored. As such, the overarching goal of this project is to examine the effects of intranasal vasopressin on several tasks involving learning and social processes. In addition, the investigators will explore associated neural activity through functional magnetic resonance imaging (fMRI). Results from the study will inform our understanding of the neurobiology of socioemotional processes.
The investigators hypothesize that compared to placebo, vasopressin will improve deception detection, increase empathy and altruism, enhance responses to photo stimuli of primary caregivers, and improve learning when the subject has a prosocial goal of teaching another person. These effects will manifest in behavioral and neural activity. It is also hypothesized that main effects will not be found for vasopressin, but rather, analyses of relevant moderators will elucidate these findings.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal vasopressin | Experimental | Drug: Intranasal vasopressinParticipants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin). |
| Intranasal placebo | Placebo comparator | Drug: Intranasal placebo2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter. Participants will self-administer 5 puffs per nostril. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-30 years of age
- Healthy (see below)
- Fluent in English
- Right-handed
Key exclusion criteria (31 listed)
- Women who gave birth in the last six months, are currently pregnant, planning to become pregnant in the next 6 months, or currently breastfeeding women
- Symptoms of runny nose due to allergies/cold or other reason
- Current restricted fluid intake for any reason
- Heart disease
- Hypertension
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 |
|---|---|---|
| Intranasal vasopressinThrough the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin). | Drug | Intranasal vasopressin |
| Intranasal placeboThrough the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: 2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter. | Drug | Intranasal placebo |
Primary outcome
Changes in neural brain activity, as observed by fMRI, when observing others during social inclusion vs. exclusion
Time frame: Between 40-115 minutes post administration
Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the vasopressin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater during the exclusion portion of the cyberball task (Williams et al., 2012) versus the inclusion portion. A first-level analysis will compare [(friend exclusion>friend inclusion)>(stranger exclusion>stranger inclusion)] for each participant. A second-level group analysis will compare these first-level contrasts between the vasopressin and placebo groups.
7 secondary outcomes
Ratings of empathic concern after witnessing social exclusion in a friend or a stranger
Time frame: Between 40-115 minutes post administration
Altruism and punishment as measured by number of points given to excluders and those excluded
Time frame: Between 40-115 minutes post administration
Changes in neural brain activity, as observed by fMRI, while attempting to detect deception
Time frame: Between 40-115 minutes post administration
Accuracy of deception detection as measured by self-report
Time frame: Between 40-115 minutes post administration
Changes in neural brain activity, as observed by fMRI, when viewing images of primary caregivers versus strangers
Time frame: Between 40-115 minutes post administration
Changes in brain neural activity, observed by fMRI, in response to a reading comprehension task
Time frame: Between 40-90 minutes post administration
Performance on a memory test of reading comprehension as measured by percentage of questions answered correctly
Time frame: Between 40-90 minutes post administration
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 10 Aug 2017.
- Derived from this study: PubMed 37310308Straccia MA, Teed AR, Katzman PL, Tan KM, Parrish MH, Irwin MR, Eisenberger NI, Lieberman MD, Tabak BA. Null results of oxytocin and vasopressin administration on mentalizing in a large fMRI sample: evidence from a randomized controlled trial. Psychol Med. 2023 Apr;53(6):2285-2295. doi: 10.1017/S0033291721004104. Epub 2021 Oct 15.
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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.
Matthew D Lieberman, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intranasal vasopressin in people with Social Psychology, run by University of California, Los Angeles 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 4 inclusion and 31 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 10 Aug 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Changes in neural brain activity, as observed by fMRI, when observing others during social inclusion vs. exclusion (time frame: Between 40-115 minutes post administration). 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 NCT02394054, 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 10 Aug 2017.