A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder
Abstract
The primary objectives of this clinical study are test the hypotheses that (1) cognitive behavioral therapy (CBT) aimed at core social dysfunctions, and (2) oxytocin (OT) administration prior to CBT sessions will each enhance social function in young adults with autism spectrum disorders (ASD), and to examine whether neuroimaging measures of brain function and structure can predict CBT treatment response. To examine these questions, we will recruit and carefully characterize 150 men, ages 18-40, with ASD to participate in this study. Participants will be randomized to receive either social skills training or a stress management/relaxation therapy, and will be randomized to receive either intranasal oxytocin or placebo. Participants and evaluators will be blind to treatment condition. In year 1 of the study, we set up the study framework, including submitting applications for approval from the MGH and MIT Internal Review Boards, and the HRPO. We also received an IND from the FDA for the use of the oxytocin, trained study staff, and began setting up recruitment efforts. The study was approved by the HRPO in April 2014, and we initiated study procedures at this time. To-date, we have enrolled 52 participants, have completed neuroimaging with 31 participants, and have randomized 35 participants into treatment. There are no study findings to report at this time, as the study is ongoing.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2016
- Accession Number
- AD1039011
Entities
People
- Aude Henin
- John Gabrieli
Organizations
- Massachusetts General Hospital