Low-dose oxytocin delivered intranasally with Breath Powered device affects social-cognitive behavior: a randomized four-way crossover trial with nasal cavity dimension assessment
Open accessAbstract
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.
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Quintana and colleagues suggest that commonly used intranasal oxytocin doses (24-40 IU) may not be the most adequate, as their results show that the intranasal oxytocin effect on emotional recognition appears with 8 IU but not with 24 IU.
“Quintana and colleagues (42) suggest that the IN-OT doses commonly used (24 -40 IU) may not be the most adequate as their results show that IN-OT effect on emotional recognition appears with an administration of 8 IU but not with 24 IU.”
From Is there a Publication Bias in Behavioural Intranasal Oxytocin Research on Humans? Opening the File Drawer of One Laboratory (2016) · cites this paper as [42]
The Introduction says commonly studied doses lack comprehensive empirical justification, and the Results (Emotional expression evaluation) report lower anger ratings for ambiguous faces after 8 IU than after both placebo and 24 IU. The claim broadens this specific anger-rating finding to emotional recognition generally; the study measured ratings of facial expressions, not recognition accuracy. (LLM, conf=0.84)
Experimental — accuracy not yet measuredOT increases perceived trustworthiness of strangers and makes social clues more salient.
“As OT increases perceived trustworthiness of strangers (52) and makes the social clues more salient (42)”
From Is there a Publication Bias in Behavioural Intranasal Oxytocin Research on Humans? Opening the File Drawer of One Laboratory (2016) · cites this paper as [42]
Citation (42) attaches to the claim that OT makes social clues more salient, not to the preceding trustworthiness claim. The Discussion (page unavailable) reports an effect on judging anger in emotionally ambiguous faces, but does not establish a general increase in the salience of social cues; it also notes no difference in ratings of angry or happy faces. (LLM, conf=0.82)
Experimental — accuracy not yet measuredExamples of promising results for nose-to-brain delivery are present in clinical trials.
“Despite these limitations, examples of promising results are present in clinical trials [19,20].”
From Nanoemulsions for “Nose-to-Brain” Drug Delivery (2019) · cites this paper as [19]
Nose-to-brain transport, rather than transport across the blood-brain barrier via peripherally circulating oxytocin, influences social cognition.
“This indicates that nose-to-brain transport, rather than transport across the blood–brain barrier via peripherally circulating oxytocin, influences social cognition.”
A single administration of intranasal 8IU oxytocin modulated social cognition in neurotypical adult males, whereas intravenous administration did not, despite comparable peripheral blood concentrations of oxytocin after intranasal and intravenous oxytocin administration.
“A single administration of intranasal 8IU oxytocin-modulated social cognition, whereas intravenous administration did not, despite comparable peripheral blood concentrations of oxytocin after intranasal and intravenous oxytocin administration.40”
Neurotypical adult males that completed the same task after placebo (n=16) had an average happiness rating of ambiguous faces of 2.51 (s.d.=0.13).
“For reference, compared to happiness rating of ambiguous faces in the present sample (Table 1), neurotypical adult males that completed the same task after placebo (n=16) had an average happiness rating of ambiguous faces of 2.51 (s.d.=0.13).40”
We previously observed a reduction in angry ratings of ambiguous faces after 8IU administration, but this was found in a sample of neurotypical adults tested in a unique fMRI environment.
“Although we previously observed a reduction in angry ratings of ambiguous faces after 8IU administration,40 this was found in a sample of neurotypical adults tested in a unique fMRI environment.”
The present result adds to existing behavioral and neural evidence that lower oxytocin doses delivered with the Breath Powered device may be more efficacious, at least for single administration trials.
“The present result also adds to existing behavioral40 and neural41 evidence that lower oxytocin doses delivered with the Breath Powered device may be more efficacious, at least for single administration trials.”
A power analysis based on effect sizes using the same primary outcome measure in healthy controls revealed a sample of 18 was sufficient to achieve statistical power of 90%.
“However, a power analysis based on effect sizes using the same primary outcome measure in healthy controls40 revealed a sample of 18 was sufficient to achieve statistical power of 90%, which is exceptionally higher than the 12% average statistical power of oxytocin clinical trials to detect the mean effect size across trials.28”
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Deilhaug, E., Moerkerke, M., Sartorius, A. M., Kang, H., Kildal, E. S.-M., Walle, K. M., Elvsåshagen, T., Westlye, L. T., Nærland, T., Andreassen, O. A., et al. (2025) · medRxiv · doi:10.1101/2025.08.25.25334355
Self-citationMendonça, T. P., Aidar, F. J., Bădicu, G., Santos, L. D. R., Paz, Â. D. A., Marçal, A. C., Orangi, B. M., Ulusoy, A., de Souza, R. F., & Brito, C. J. (2026) · European Journal of Applied Physiology · doi:10.1007/s00421-026-06163-3
- Authors
- Quintana, D. S., Westlye, L. T., Rustan, Ø. G., Tesli, N., Poppy, C. L., Smevik, H., Tesli, M., Røine, M., Mahmoud, R. A., Smerud, K. T., Djupesland, P. G., & Andreassen, O. A.
- Affiliations
- Oslo University Hospital (NO)
- Smerud Medical Research (Norway) (NO)
- OptiNose (United States) (US)
- OptiNose (Norway) (NO)
- Corresponding author
- Andreassen, O A
- ORCID
- Venue
- Translational Psychiatry
- Published
- 2015-07-14
- Volume
- 5
- Issue
- 7
- Pages
- e602-e602
- ISSN
- 2158-3188 (ISSN-L)
- PMC
- PMC5068727
- OpenAlex
- W1606631727
- Cited by
- 103
- References
- 92
- Citations by year
- 2026: 7 · 2025: 8 · 2024: 12 · 2023: 7 · 2022: 5 · 2021: 8 · 2020: 13 · 2019: 8 · 2018: 9 · 2017: 10 · 2016: 11 · 2015: 5
- FWCI
- 19.09
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Translational Psychiatry (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- ePrints Soton (University of Southampton) (acceptedVersion)
- NORA - Norwegian Open Research Archives (submittedVersion, cc-by)
- Funders
- Universitetet i Oslo
- Norges Forskningsråd (223273, 219483)
- Topics
- Social Sciences › Psychology › Social Psychology › Neuroendocrine regulation and behavior
- Life Sciences › Neuroscience › Sensory Systems › Olfactory and Sensory Function Studies
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advanced Drug Delivery Systems
- Keywords
- intranasal oxytocin, nose-to-brain transport, social cognition, nasal cavity dimensions, nasal valve, vasopressin, cortisol, low-dose oxytocin, intravenous oxytocin, drug deposition
- MeSH terms
- Administration, Intranasal, Adult, Double-Blind Method, Facial Expression, Humans, Hydrocortisone, Magnetic Resonance Imaging, Male, Nasal Cavity, Oxytocin, Social Behavior, Social Perception, Vasopressins, Cross-Over Studies, Young Adult, Neuroimaging
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