title: Recommendations for the standardisation of oxytocin nasal administration and guidelines for its reporting in human research.
abstract: A series of studies have reported on the salubrious effects of oxytocin nasal spray on social cognition and behavior in humans, across physiology (e.g., eye gaze, heart rate variability), social cognition (e.g., attention, memory, and appraisal), and behavior (e.g., trust, generosity). Findings suggest the potential of oxytocin nasal spray as a treatment for various psychopathologies, including autism and schizophrenia. There are, however, increasing reports of variability of response to oxytocin nasal spray between experiments and individuals. In this review, we provide a summary of factors that influence transmucosal nasal drug delivery, deposition, and their impact on bioavailability. These include variations in anatomy and resultant airflow dynamic, vascularisation, status of blood vessels, mode of spray application, gallenic formulation (including presence of uptake enhancers, control release formulation), and amount and method of administration. These key variables are generally poorly described and controlled in scientific reports, in spite of their potential to alter the course of treatment outcome studies. Based on this review, it should be of no surprise that differences emerge across individuals and experiments when nasal drug delivery methods are employed. We present recommendations for researchers to use when developing and administering the spray, and guidelines for reporting on peptide nasal spray studies in humans. We hope that these recommendations assist in establishing a scientific standard that can improve the rigor and subsequent reliability of reported effects of oxytocin nasal spray in humans.
authors.affiliation: Brain & Mind Research Institute, University of Sydney, Sydney 2006, Australia. adam.guastella@sydney.edu.au
authors.forename: Adam J
authors.initials: AJ
authors.lastname: Guastella
authors.forename: Ian B
authors.initials: IB
authors.lastname: Hickie
authors.forename: Margaret M
authors.initials: MM
authors.lastname: McGuinness
authors.forename: Melissa
authors.initials: M
authors.lastname: Otis
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Woods
authors.forename: Hannah M
authors.initials: HM
authors.lastname: Disinger
authors.forename: Hak-Kim
authors.initials: HK
authors.lastname: Chan
authors.forename: Timothy F
authors.initials: TF
authors.lastname: Chen
authors.forename: Richard B
authors.initials: RB
authors.lastname: Banati
mesh_terms: D000281:Administration, Intranasal / Q000592:standards; D000327:Adsorption; D006805:Human Experimentation / Q000592:standards; D006801:Humans; D009297:Nasal Mucosa / Q000378:metabolism; D059085:Nasal Sprays; D009666:Nose / Q000033:anatomy & histology; D010121:Oxytocin / Q000008:administration & dosage* / Q000493:pharmacokinetics; D017410:Practice Guidelines as Topic; D012107:Research Design / Q000592:standards*
chemical_list: D059085:Nasal Sprays; D010121:Oxytocin