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Study · Randomized controlled trial · n = 17 · 2017

6 results

Dose-dependent social-cognitive effects of intranasal oxytocin delivered with novel Breath Powered device in adults with autism spectrum disorder: a randomized placebo-controlled double-blind crossover trial.

Quintana DS, Westlye LT, Hope S, Nærland T, Elvsåshagen T, Dørum E, Rustan Ø, Valstad M, Rezvaya L, Lishaugen H, Stensønes E, Yaqub S and 4 more

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Smerud KT, Mahmoud RA, Djupesland PG, Andreassen OA

Translational psychiatry23 May 2017Cited by 71 (Europe PMC)

Summary

The neuropeptide oxytocin has shown promise as a treatment for symptoms of autism spectrum disorders (ASD). However, clinical research progress has been hampered by a poor understanding of oxytocin's dose-response and sub-optimal intranasal delivery methods. We examined two doses of oxytocin delivered using a novel Breath Powered intranasal delivery device designed to improve direct nose-to-brain activity in a double-blind, crossover, randomized, placebo-controlled trial. In a randomized sequence of single-dose sessions, 17 male adults with ASD received 8 international units (IU) oxytocin, 24IU oxytocin or placebo followed by four social-cognitive tasks. We observed an omnibus main effect of treatment on the primary outcome measure of overt emotion salience as measured by emotional ratings of faces (η2=0.18). Compared to placebo, 8IU treatment increased overt emotion salience (P=0.02, d=0.63). There was no statistically significant increase after 24IU treatment (P=0.12, d=0.4). The effects after 8IU oxytocin were observed despite no significant increase in peripheral blood plasma oxytocin concentrations. We found no significant effects for reading the mind in the eyes task performance or secondary outcome social-cognitive tasks (emotional dot probe and face-morphing). To our knowledge, this is the first trial to assess the dose-dependent effects of a single oxytocin administration in autism, with results indicating that a low dose of oxytocin can significantly modulate overt emotion salience despite minimal systemic exposure.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adult men with autism, an omnibus main effect of oxytocin treatment occurred on overt emotion salience, the primary outcome.

    In plain wordsIn men with autism, oxytocin treatment had an overall effect on how strongly emotions in faces were rated.

    Peptide
    Oxytocin
    Outcome
    Not applicableOvert emotion salience, omnibus treatment effect
    Study

    n = 17

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    8 IU and 24 IU · intranasalAs given in this study (human).

    Measurements

    eta squared
    0.18
    omnibus treatment effect

    Source sentences

    Summary
    We observed an omnibus main effect of treatment on the primary outcome measure of overt emotion salience as measured by emotional ratings of faces (η2=0.18).
    1 context sentence
    Summary · context
    In a randomized sequence of single-dose sessions, 17 male adults with ASD received 8 international units (IU) oxytocin, 24IU oxytocin or placebo followed by four social-cognitive tasks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adult men with autism, 8 IU intranasal oxytocin increased overt emotion salience compared with placebo.

    In plain wordsIn men with autism, a low oxytocin dose increased how strongly emotions in faces were rated, compared with placebo.

    Peptide
    Oxytocin
    Outcome
    IncreaseOvert emotion salience, 8 IU
    Study

    n = 17

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    8 IU · intranasalAs given in this study (human).

    Measurements

    Cohen d
    0.63
    8 IU
    P value
    0.02
    8 IU

    Source sentences

    Summary
    Compared to placebo, 8IU treatment increased overt emotion salience (P=0.02, d=0.63).
    1 context sentence
    Summary · context
    In a randomized sequence of single-dose sessions, 17 male adults with ASD received 8 international units (IU) oxytocin, 24IU oxytocin or placebo followed by four social-cognitive tasks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adult men with autism, 24 IU intranasal oxytocin produced no statistically significant increase in overt emotion salience compared with placebo.

    In plain wordsIn men with autism, a higher oxytocin dose did not significantly change how strongly emotions in faces were rated, compared with placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changeOvert emotion salience, 24 IU
    Study

    n = 17

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    24 IU · intranasalAs given in this study (human).

    Measurements

    Cohen d
    0.4
    24 IU
    P value
    0.12
    24 IU

    Source sentences

    Summary
    There was no statistically significant increase after 24IU treatment (P=0.12, d=0.4).
    1 context sentence
    Summary · context
    In a randomized sequence of single-dose sessions, 17 male adults with ASD received 8 international units (IU) oxytocin, 24IU oxytocin or placebo followed by four social-cognitive tasks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adult men with autism, oxytocin had no significant effects on the secondary emotional dot probe and face-morphing tasks.

    In plain wordsIn men with autism, oxytocin did not significantly change results on two further social tasks.

    Peptide
    Oxytocin
    Outcome
    No significant changeSecondary social-cognitive tasks (emotional dot probe and face-morphing)
    Study

    n = 17

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    8 IU and 24 IU · intranasalAs given in this study (human).

    Source sentences

    Summary
    secondary outcome social-cognitive tasks (emotional dot probe and face-morphing).
    1 context sentence
    Summary · context
    In a randomized sequence of single-dose sessions, 17 male adults with ASD received 8 international units (IU) oxytocin, 24IU oxytocin or placebo followed by four social-cognitive tasks.
  5. 05HumanRandomized controlled trialPharmacokinetics

    In adult men with autism, plasma oxytocin concentrations showed no significant increase after 8 IU intranasal oxytocin.

    In plain wordsIn men with autism, blood oxytocin levels did not rise significantly after the low dose.

    Peptide
    Oxytocin
    Outcome
    No significant changePeripheral plasma oxytocin concentration after 8 IU
    Study

    n = 17

    Comparator
    Placebo
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    8 IU · intranasalAs given in this study (human).

    Source sentences

    Summary
    The effects after 8IU oxytocin were observed despite no significant increase in peripheral blood plasma oxytocin concentrations.
    1 context sentence
    Summary · context
    In a randomized sequence of single-dose sessions, 17 male adults with ASD received 8 international units (IU) oxytocin, 24IU oxytocin or placebo followed by four social-cognitive tasks.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In adult men with autism, oxytocin had no significant effect on Reading the Mind in the Eyes task performance.

    In plain wordsIn men with autism, oxytocin did not significantly change performance on the eye-reading emotion task.

    Peptide
    Oxytocin
    Outcome
    No significant changeReading the Mind in the Eyes task performance
    Study

    n = 17

    Comparator
    Placebo
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    8 IU and 24 IU · intranasalAs given in this study (human).

    Source sentences

    Summary
    We found no significant effects for reading the mind in the eyes task performance or secondary outcome social-cognitive tasks (emotional dot probe and face-morphing).
    1 context sentence
    Summary · context
    In a randomized sequence of single-dose sessions, 17 male adults with ASD received 8 international units (IU) oxytocin, 24IU oxytocin or placebo followed by four social-cognitive tasks.

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

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.

  1. Version 2Current

    11 Oct 2026, 01:30 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 02:49 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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