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Trial · Interventional

CompletedEarly phase 1Registry data

Neuropeptides and Social Behavior

NCTNCT01680718 (opens ClinicalTrials.gov in a new tab)Other idBehavioral Neuropeptides

Overview

Status
Completed
Phase
Early phase 1
Enrollment
160 participants (actual)
Sponsor
University of California, Los Angeles · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Oct 2012
Primary completion
Sept 2013
Completion
Sept 2013
First posted
7 Sept 2012 (estimated)
Last update posted
28 May 2015 (estimated)
Conditions
Social Psychology

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph Early 1

    Neuropeptides and Social Behavior

    NCT01680718

    Oct 2012 to Sept 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Intranasal oxytocinDrug
  • Intranasal vasopressinDrug
  • Intranasal placeboDrug

Arms3

  • Experimental

    Intranasal oxytocin

    Participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).

  • Experimental

    Intranasal vasopressin

    Participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).

  • Placebo comparator

    Intranasal placebo

    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.

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Speed in social working memory task

    Time frame · Between 40-90 minutes post administration

    Registry description

    Between group differences in the amount of time it takes to perform tasks involving social working memory

  2. Accuracy of deception detection based on self-report

    Time frame · Between 40-90 minutes post administration

    Registry description

    Between group differences in deception detection accuracy based on self-reported ratings of unfamiliar others

  3. Self-reported perceptions of trust and threat

    Time frame · Between 40-90 minutes post administration

    Registry description

    Between group differences in self-reported perceptions of trust and threat towards unfamiliar faces which appear to vary in interpersonal distance

  4. Self-reported empathy and altruistic behavior

    Time frame · Between 40-90 minutes post administration

    Registry description

    Between group differences in self-reported empathy (empathic concern and personal distress), and altruistic behavior.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2019

2 results

Null results of oxytocin and vasopressin administration across a range of social cognitive and behavioral paradigms: Evidence from a randomized controlled trial.

Tabak et al. 2019Psychoneuroendocrinologycited by 36

PMID 31128568PMC6687062DOI 10.1016/j.psyneuen.2019.04.019PUB-31128568

Rights unknown2 results

Indexing hint: Randomized controlled trial · 2016

2 results

Oxytocin, but not vasopressin, impairs social cognitive ability among individuals with higher levels of social anxiety: a randomized controlled trial.

Tabak et al. 2016Social cognitive and affective neurosciencecited by 17

PMID 27053769PMC4967803DOI 10.1093/scan/nsw041PUB-27053769

Free to read · publisher termsCC BY-NC2 results

Indexing hint: Randomized controlled trial · 2015

1 result

Vasopressin, but not oxytocin, increases empathic concern among individuals who received higher levels of paternal warmth: A randomized controlled trial.

Tabak et al. 2015Psychoneuroendocrinologycited by 46

PMID 25462898PMC4268337DOI 10.1016/j.psyneuen.2014.10.006PUB-25462898

Rights unknown1 result

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 50 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 18-50 years of age * Healthy (see below) * Fluent in English Exclusion Criteria: * 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 * 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

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