Social PsychologyEarly Phase 1NCT01680718
Neuropeptides and Social Behavior
A Early Phase 1 study testing Intranasal oxytocin and 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, we 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 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Psychology
- What is being tested?
- Intranasal oxytocin and Intranasal vasopressin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Sep 2013
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-50 years of age
- Healthy (see below)
- Fluent in English
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 28Show 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 (>130/90)
- Low blood pressure (<90/60)
- Body temperature >100.1 F
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Department of Psychology
Los Angeles, California, 90095-1563
About this study
It has long been established that interpersonal relationships can have a profound impact on health and well-being. Yet, we 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 oxytocin and vasopressin, neuropeptides that are naturally produced in the hypothalamus, because administration of these neuropeptides has been associated with increased trust, generosity, 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 oxytocin and vasopressin's effects on social behavior have been unexplored. As such, the overarching goal of this project is to examine the effects of intranasal oxytocin and vasopressin on social working memory, deception detection, sensitivity to interpersonal distance, empathy, and altruistic behavior. Understanding how oxytocin and vasopressin influence these aspects of social functioning will help to inform research that has begun to establish the potential for use of these neuropeptides in psychiatric disorders such as autism spectrum disorders and schizophrenia that are characterized by social deficits. For this study, we will recruit 150 healthy adults without a history of medical or psychiatric illness to come to the laboratory. In the first session, participants will complete several questionnaires. In the second session, participants will be randomly assigned to receive oxytocin, vasopressin, or placebo. The study nurses will measure temperature, heart rate, and blood pressure (female participants will also be asked to undergo a pregnancy test) before drug administration. Participants will then complete computer tasks. During the second session, we will also collect a saliva sample for genetic analysis and participants will be asked to complete several additional questionnaires. At the end of the experimental session, participants will be fully debriefed.
The investigators hypothesize that compared to placebo, oxytocin and/or vasopressin will improve social working memory and deception detection, and increase empathy and altruism. It is also hypothesized that main effects will not be found for oxytocin or vasopressin, but rather, analyses of relevant moderators will elucidate these findings.
- Conditions
- Social Psychology
- Being tested
- Intranasal oxytocin, Intranasal vasopressin, Intranasal placebo
- Keywords
- oxytocin, 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 oxytocinDrug
Also called Syntocinon nasal spray
Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).
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 (used previously; Bartz et al., 2010).
| Study group | Role | What they receive |
|---|---|---|
| Intranasal oxytocin | Experimental | Participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin). Receives: Drug: Intranasal oxytocin |
| 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 (used previously; Bartz et al., 2010). 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.
Speed in social working memory task
Between group differences in the amount of time it takes to perform tasks involving social working memory
Measured: Between 40-90 minutes post administration
Accuracy of deception detection based on self-report
Between group differences in deception detection accuracy based on self-reported ratings of unfamiliar others
Measured: Between 40-90 minutes post administration
Self-reported perceptions of trust and threat
Between group differences in self-reported perceptions of trust and threat towards unfamiliar faces which appear to vary in interpersonal distance
Measured: Between 40-90 minutes post administration
Self-reported empathy and altruistic behavior
Between group differences in self-reported empathy (empathic concern and personal distress), and altruistic behavior.
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 posted7 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naomi Eisenberger, University of California, Los Angeles
- Investigators
- Naomi I Eisenberger, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680718
- Sponsor's protocol ID
- Behavioral Neuropeptides
- Status last verified
- May 2015
- First submitted
- 31 Aug 2012
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tabak BA, Teed AR, Castle E, Dutcher JM, Meyer ML, Bryan R, Irwin MR, Lieberman MD, Eisenberger NI. Null results of oxytocin and vasopressin administration across a range of social cognitive and behavioral paradigms: Evidence from a randomized controlled trial. Psychoneuroendocrinology. 2019 Sep;107:124-132. doi: 10.1016/j.psyneuen.2019.04.019. Epub 2019 Apr 29.
PubMed 31128568Tabak BA, Meyer ML, Dutcher JM, Castle E, Irwin MR, Lieberman MD, Eisenberger NI. Oxytocin, but not vasopressin, impairs social cognitive ability among individuals with higher levels of social anxiety: a randomized controlled trial. Soc Cogn Affect Neurosci. 2016 Aug;11(8):1272-9. doi: 10.1093/scan/nsw041. Epub 2016 Apr 6.
PubMed 27053769Tabak BA, Meyer ML, Castle E, Dutcher JM, Irwin MR, Han JH, Lieberman MD, Eisenberger NI. Vasopressin, but not oxytocin, increases empathic concern among individuals who received higher levels of paternal warmth: A randomized controlled trial. Psychoneuroendocrinology. 2015 Jan;51:253-61. doi: 10.1016/j.psyneuen.2014.10.006. Epub 2014 Oct 17.
PubMed 25462898
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropeptides and Social Behavior
- ClinicalTrials.gov ID
- NCT01680718
- Acronym / sponsor ID
- Behavioral Neuropeptides
- Conditions
- Social Psychology
- Keywords
- oxytocin, vasopressin, intranasal administration, healthy sample
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 7 Sep 2012 (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, we 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 oxytocin and vasopressin, neuropeptides that are naturally produced in the hypothalamus, because administration of these neuropeptides has been associated with increased trust, generosity, 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 oxytocin and vasopressin's effects on social behavior have been unexplored. As such, the overarching goal of this project is to examine the effects of intranasal oxytocin and vasopressin on social working memory, deception detection, sensitivity to interpersonal distance, empathy, and altruistic behavior. Understanding how oxytocin and vasopressin influence these aspects of social functioning will help to inform research that has begun to establish the potential for use of these neuropeptides in psychiatric disorders such as autism spectrum disorders and schizophrenia that are characterized by social deficits. For this study, we will recruit 150 healthy adults without a history of medical or psychiatric illness to come to the laboratory. In the first session, participants will complete several questionnaires. In the second session, participants will be randomly assigned to receive oxytocin, vasopressin, or placebo. The study nurses will measure temperature, heart rate, and blood pressure (female participants will also be asked to undergo a pregnancy test) before drug administration. Participants will then complete computer tasks. During the second session, we will also collect a saliva sample for genetic analysis and participants will be asked to complete several additional questionnaires. At the end of the experimental session, participants will be fully debriefed.
The investigators hypothesize that compared to placebo, oxytocin and/or vasopressin will improve social working memory and deception detection, and increase empathy and altruism. It is also hypothesized that main effects will not be found for oxytocin or vasopressin, but rather, analyses of relevant moderators will elucidate these findings.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intranasal oxytocin | Experimental | Drug: Intranasal oxytocinParticipants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin). |
| 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 (used previously; Bartz et al., 2010). Participants will self-administer 5 puffs per nostril. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-50 years of age
- Healthy (see below)
- Fluent in English
Key exclusion criteria (28 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 oxytocinAlso: Syntocinon nasal sprayThrough the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin). | Drug | Intranasal oxytocin |
| 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 (used previously; Bartz et al., 2010). | Drug | Intranasal placebo |
Primary outcome
Speed in social working memory task
Time frame: Between 40-90 minutes post administration
Between group differences in the amount of time it takes to perform tasks involving social working memory
Accuracy of deception detection based on self-report
Time frame: Between 40-90 minutes post administration
Between group differences in deception detection accuracy based on self-reported ratings of unfamiliar others
Self-reported perceptions of trust and threat
Time frame: Between 40-90 minutes post administration
Between group differences in self-reported perceptions of trust and threat towards unfamiliar faces which appear to vary in interpersonal distance
Self-reported empathy and altruistic behavior
Time frame: Between 40-90 minutes post administration
Between group differences in self-reported empathy (empathic concern and personal distress), and altruistic behavior.
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 28 May 2015.
- Derived from this study: PubMed 31128568Tabak BA, Teed AR, Castle E, Dutcher JM, Meyer ML, Bryan R, Irwin MR, Lieberman MD, Eisenberger NI. Null results of oxytocin and vasopressin administration across a range of social cognitive and behavioral paradigms: Evidence from a randomized controlled trial. Psychoneuroendocrinology. 2019 Sep;107:124-132. doi: 10.1016/j.psyneuen.2019.04.019. Epub 2019 Apr 29.
- Derived from this study: PubMed 27053769Tabak BA, Meyer ML, Dutcher JM, Castle E, Irwin MR, Lieberman MD, Eisenberger NI. Oxytocin, but not vasopressin, impairs social cognitive ability among individuals with higher levels of social anxiety: a randomized controlled trial. Soc Cogn Affect Neurosci. 2016 Aug;11(8):1272-9. doi: 10.1093/scan/nsw041. Epub 2016 Apr 6.
- Derived from this study: PubMed 25462898Tabak BA, Meyer ML, Castle E, Dutcher JM, Irwin MR, Han JH, Lieberman MD, Eisenberger NI. Vasopressin, but not oxytocin, increases empathic concern among individuals who received higher levels of paternal warmth: A randomized controlled trial. Psychoneuroendocrinology. 2015 Jan;51:253-61. doi: 10.1016/j.psyneuen.2014.10.006. Epub 2014 Oct 17.
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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.
Naomi I Eisenberger, 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 oxytocin and 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 3 inclusion and 28 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 28 May 2015. 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?
Speed in social working memory task (time frame: Between 40-90 minutes post administration). The study lists 4 primary outcomes in all. 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 NCT01680718, which also lists 3 linked publications.
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 28 May 2015.