A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder

What Was Tested

This registered phase 2 trial tested Oxytocin.

This 3-year study is a trial of cognitive behavioral therapy (CBT), with or without oxytocin (OT) augmentation, in young adults with autism spectrum disorders.

Participants will be randomly assigned to receive either a social skills-focused CBT intervention or a stress management/relaxation training CBT intervention.

Participants will also be randomized to receive either a) intranasal oxytocin or b) a placebo drug, prior to the psychotherapy.

It had four arms (groups): Social Skills Focused CBT (experimental), Stress Management/Relaxation Training (active comparator), Oxytocin (experimental) and placebo drug (placebo comparator).

Twelve weekly 60-minute sessions of social skills focused CBT.

Twelve weekly 60-minute sessions of stress management training.

The registry classes the interventions as behavioral and drug.

Who Took Part

Enrollment: 92 actual participants took part.

It was open to men only aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Able to attend in person therapy sessions in Boston. Normal or corrected vision. IQ \> 90, as determined by the WASI.

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: current use of certain endocrinologically relevant medications; current dependence on substances other than tobacco or caffeine; history of serious medical illness, including neurological, endocrine, cardiac, respiratory, and metabolic diseases that are counter-indications to oxytocin.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

The Oxytocin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2014-04 with completion listed for 2017-11.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes in the Autism Diagnostic Observation Schedule (ADOS) (time frame: At baseline and after 12 weeks of treatment). Clinical Global Impression Scale (CGI) (time frame: At baseline and every 4 week up to 12 weeks).

It also tracked 3 secondary outcomes, for example Social Responsiveness Scale (SRS), Reading the Mind in the Eyes Test (RMET) and Social Ball Tossing Task.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 92 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.