Low-dose oxytocin delivered intranasally with Breath Powered device affects social-cognitive behavior: a randomized four-way crossover trial with nasal cavity dimension assessment.

Quintana DS, Westlye LT, Rustan ØG, Tesli N, Poppy CL, Smevik H, Tesli M, Røine M, Mahmoud RA, Smerud KT, Djupesland PG, Andreassen OA

Translational psychiatry14 Jul 2015Cited by 89 (Europe PMC)

PMID26171983PMCIDPMC5068727DOI10.1038/tp.2015.93PepBankPUB-26171983

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Summary

Despite the promise of intranasal oxytocin (OT) for modulating social behavior, recent work has provided mixed results. This may relate to suboptimal drug deposition achieved with conventional nasal sprays, inter-individual differences in nasal physiology and a poor understanding of how intranasal OT is delivered to the brain in humans. Delivering OT using a novel 'Breath Powered' nasal device previously shown to enhance deposition in intranasal sites targeted for nose-to-brain transport, we evaluated dose-dependent effects on social cognition, compared response with intravenous (IV) administration of OT, and assessed nasal cavity dimensions using acoustic rhinometry. We adopted a randomized, double-blind, double-dummy, crossover design, with 16 healthy male adults completing four single-dose treatments (intranasal 8 IU (international units) or 24 IU OT, 1 IU OT IV and placebo). The primary outcome was social cognition measured by emotional ratings of facial images. Secondary outcomes included the pharmacokinetics of OT, vasopressin and cortisol in blood and the association between nasal cavity dimensions and emotional ratings. Despite the fact that all the treatments produced similar plasma OT increases compared with placebo, there was a main effect of treatment on anger ratings of emotionally ambiguous faces. Pairwise comparisons revealed decreased ratings after 8 IU OT in comparison to both placebo and 24 IU OT. In addition, there was an inverse relationship between nasal valve dimensions and anger ratings of ambiguous faces after 8-IU OT treatment. These findings provide support for a direct nose-to-brain effect, independent of blood absorption, of low-dose OT delivered from a Breath Powered device.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialPharmacokinetics
In healthy men, intranasal (8 IU, 24 IU) and intravenous (1 IU) oxytocin all produced similar plasma oxytocin increases compared with placebo.
In plain wordsIn healthy men, every oxytocin treatment raised blood oxytocin by a similar amount compared with placebo.
Peptide
Oxytocin
Outcome
IncreasePlasma oxytocin increase
Study
n = 16
Comparator
Placebo
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
8 IU or 24 IU intranasal; 1 IU intravenous · intranasal and intravenous · single doseAs given in this study (human).
Source sentences
Summary
Despite the fact that all the treatments produced similar plasma OT increases compared with placebo
1 context sentence(design, population, supporting numbers)
Summary · context
We adopted a randomized, double-blind, double-dummy, crossover design, with 16 healthy male adults completing four single-dose treatments (intranasal 8 IU (international units) or 24 IU OT, 1 IU OT IV and placebo).
Show in the study text Report a problemFND-2617198301
02HumanRandomized controlled trialEfficacy outcome
In healthy men, intranasal 8 IU oxytocin decreased anger ratings of emotionally ambiguous faces compared with placebo.
In plain wordsIn healthy men, a low nasal dose of oxytocin lowered anger ratings of unclear faces compared with placebo.
Peptide
Oxytocin
Outcome
DecreaseAnger ratings of ambiguous faces, 8 IU versus placebo
Study
n = 16
Comparator
Placebo
Outcome group
Social behavior and cognition · Nervous system and cognition
Studied dose
8 IU · intranasal · single doseAs given in this study (human).
Source sentences
Summary
Pairwise comparisons revealed decreased ratings after 8 IU OT in comparison to both placebo and 24 IU OT.
2 context sentences(design, population, supporting numbers)
Summary · context
there was a main effect of treatment on anger ratings of emotionally ambiguous faces.
Summary · context
We adopted a randomized, double-blind, double-dummy, crossover design, with 16 healthy male adults completing four single-dose treatments (intranasal 8 IU (international units) or 24 IU OT, 1 IU OT IV and placebo).
Show in the study text Report a problemFND-2617198302
03HumanRandomized controlled trialEfficacy outcome
In healthy men, intranasal 8 IU oxytocin decreased anger ratings of emotionally ambiguous faces compared with 24 IU oxytocin.
In plain wordsIn healthy men, the low nasal dose of oxytocin lowered anger ratings of unclear faces more than the higher nasal dose.
Peptide
Oxytocin
Outcome
DecreaseAnger ratings of ambiguous faces, 8 IU versus 24 IU
Study
n = 16
Comparator
24 IU intranasal oxytocin
Outcome group
Social behavior and cognition · Nervous system and cognition
Studied dose
8 IU · intranasal · single doseAs given in this study (human).
Source sentences
Summary
Pairwise comparisons revealed decreased ratings after 8 IU OT in comparison to both placebo and 24 IU OT.
1 context sentence(design, population, supporting numbers)
Summary · context
We adopted a randomized, double-blind, double-dummy, crossover design, with 16 healthy male adults completing four single-dose treatments (intranasal 8 IU (international units) or 24 IU OT, 1 IU OT IV and placebo).
Show in the study text Report a problemFND-2617198303
04HumanRandomized controlled trialMechanism
In healthy men, nasal valve dimensions were inversely related to anger ratings of ambiguous faces after intranasal 8 IU oxytocin.
In plain wordsIn healthy men, wider nasal valves were linked to lower anger ratings of unclear faces after a low nasal dose of oxytocin.
Peptide
Oxytocin
Outcome
Not applicableAssociation of nasal valve dimensions with anger ratings after 8 IU
Study
n = 16
Outcome group
Social behavior and cognition · Nervous system and cognition
Studied dose
8 IU · intranasal · single doseAs given in this study (human).
Source sentences
Summary
In addition, there was an inverse relationship between nasal valve dimensions and anger ratings of ambiguous faces after 8-IU OT treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
We adopted a randomized, double-blind, double-dummy, crossover design, with 16 healthy male adults completing four single-dose treatments (intranasal 8 IU (international units) or 24 IU OT, 1 IU OT IV and placebo).
Show in the study text Report a problemFND-2617198304

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT01983514

Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Healthy Adults

OptiNose ASn = 19Oct 2013 to Feb 2014

Healthy Male Adults

Trial page ClinicalTrials.govUpdated 23 Apr 2014

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
11 Oct 2026, 01:30 UTC
Study results updated
Version 1
9 Oct 2026, 02:50 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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