A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder
Status:
Completed
Trial end date:
2017-11-01
Target enrollment:
Participant gender:
Summary
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. The
design of the study will enable examination of the efficacy of CBT for young adults with
autism spectrum disorders. The design of the study will also allow examination of whether
oxytocin enhances the efficacy of CBT.
The investigators will perform functional (fMRI) and structural (MRI) imaging with all
participants prior to treatment. This will enable examination of the relations between
measures of brain function and structure, and improvements in target symptoms over the course
of treatment. The aim is to discover whether there are neural characteristics that can
identify which participants with autism spectrum disorders are most likely to respond to CBT
interventions and/or oxytocin treatment.