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Neuropeptides and Social Behavior
Plain-language guide to NCT01680718: early phase 1 randomized trial of Oxytocin and Vasopressin, 160 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01680718
- Phase
- early phase 1
- Status
- completed
- Start
- 2012-10
- Completion (planned or actual)
- 2013-09
- Participants
- 160 (actual)
- Design
- randomized, double-blind, basic_science
- Conditions studied
- Social Psychology
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (early phase 1) is built around Oxytocin and Vasopressin.
It has long been established that interpersonal relationships can have a profound impact on health and well-being.
Yet, the researchers are still learning about the complex biological processes that contribute to positive social interactions and the ability to develop and maintain social relationships.
It had three arms (groups): Intranasal oxytocin (experimental), Intranasal vasopressin (experimental) and Intranasal placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 160 actual participants took part.
It was open to people of any sex aged from 18 years up to 50 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: 18-50 years of age. Healthy (see below). Fluent in English.
The full record lists 3 inclusion and 28 exclusion criteria; among the exclusions: 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.
How the Study Was Run
The set-up was randomized, factorial and double-blind.
The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.
As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2012-10 with completion listed for 2013-09.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
Primary outcome: Speed in social working memory task (time frame: Between 40-90 minutes post administration). Accuracy of deception detection based on self-report (time frame: Between 40-90 minutes post administration). Self-reported perceptions of trust and threat (time frame: Between 40-90 minutes post administration).
What This Means in Plain Language
Put simply, this is a early phase 1, randomized trial of Oxytocin and Vasopressin in 160 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Oxytocin compound page and the Vasopressin compound page, all human trials.
Our Notes on the Compounds
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
Vasopressin: A 9-amino-acid hormone (antidiuretic hormone) that controls water balance and blood vessel tone; used in septic shock.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.