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The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories
Plain-language guide to NCT03031405: not phased randomized trial of Oxytocin, 220 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03031405
- Phase
- not phased
- Status
- completed
- Start
- 2017-01-15
- Completion (planned or actual)
- 2018-06-30
- Participants
- 220 (actual)
- Design
- randomized, triple-blind, basic_science
- Conditions studied
- Intrusive Memories
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Oxytocin.
The purpose of the study is to examine whether oxytocin and oxytocin receptor gene polymorphism affect the development of intrusive memories, a cardinal symptom of PTSD.
It had two arms (groups): Oxytocin and trauma film paradigm (experimental) and Placebo and trauma film paradigm (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 220 actual participants took part.
It was open to women only aged from 18 years up to 44 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: German on a native level.
The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: any physical illnesses; any medication intake (except oral contraceptive); history of traumatic experience, e.g. history of sexual abuse or rape.
How the Study Was Run
The set-up was randomized, factorial and triple-blind.
The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.
Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.
Those kept unaware of assignments: participant, investigator and outcomes assessor.
It started in 2017-01-15 with completion listed for 2018-06-30.
It ran at 1 site in Germany.
Its stated primary purpose is basic science.
What Was Measured
Primary outcome: Intrusive memories (time frame: four consecutive days).
It also tracked 3 secondary outcomes, for example Noradrenergic System (measured with salivary alpha-amylase - u/ml), Genetic polymorphism and Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Oxytocin in 220 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, all human trials.
Our Notes on the Compound
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
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.