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Clinical Trial
. 2017 May 23;7(5):e1136.
doi: 10.1038/tp.2017.103.

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

D S Quintana  1   2 , L T Westlye  1   2   3 , S Hope  1   2   4 , T Nærland  1   2   5 , T Elvsåshagen  1   2   6   7 , E Dørum  1   2 , Ø Rustan  1   2 , M Valstad  1   2   3 , L Rezvaya  1   2   3 , H Lishaugen  1   2   3 , E Stensønes  1   2   3 , S Yaqub  1   2   3 , K T Smerud  8 , R A Mahmoud  9 , P G Djupesland  10 , O A Andreassen  1   2
Affiliations
Clinical Trial

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

D S Quintana et al. Transl Psychiatry. .

Abstract

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.

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Conflict of interest statement

PGD is an employee of OptiNose AS, Oslo, Norway and owns stock and stock options in OptiNose. RAM is an employee of OptiNose US, Yardley, PA, USA and owns stock and stock options in OptiNose. OAA has received speaker’s honoraria from GSK, Lundbeck and Otsuka for work not directly relevant to the submitted manuscript. KTS is employed by Smerud Medical Research International AS, a CRO receiving fees for clinical trial services from OptiNose AS. The remaining authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Task design. Participants were administered an intranasal solution with the social-cognitive tasks beginning 40 min after intranasal administration. Blood samples and the STAI responses (state-trait anxiety questionnaire) were also collected twice, before and after intranasal administration. Time is shown in minutes.
Figure 2
Figure 2
Mean scores for emotion sensitivity ratings. Happy ratings of ambiguous faces were increased after 8 international units (IU) oxytocin treatment (a). Angry ratings of ambiguous faces were also increased after 8IU treatment; however, this was on the border of statistical significance (b). There were no significant differences in happy ratings of happy faces (c) or angry ratings of angry faces (d). Error bars represent standard error of the mean and were corrected for a within-subject design.,
Figure 3
Figure 3
Mean RMET scores. There was also no significant difference in Reading the Mind in the Eyes Test (RMET) performance between treatment conditions. Error bars represent standard error of the mean and were corrected for a within-subject design., IU, international units.
Figure 4
Figure 4
Hormone pharmacokinetics. Pharmacokinetics of plasma oxytocin (a), arginine vasopressin (AVP) (b), and cortisol (c) before and after each treatment administration. Error bars represent standard error of the mean and were corrected for a within-subjects design., IU, international units.
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