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

Completed · Phase 2 · Has a placebo group

Conditions studied: Autism Spectrum Disorders

In brief

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.

Key facts

Study ID

NCT01914939

Run by

Massachusetts General Hospital

People needed

92

Starts

2014-04-01

Expected to finish

2017-11-01

Last updated by the study team

2020-01-27

Who can join

Age: 18 and older, up to 40. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-40
• Able to attend in person therapy sessions in Boston
• Male
• English-speaking
• Normal or corrected vision
• No history of known genetic disorder, significant motor developmental difficulties, prematurity or brain injury
• IQ > 90, as determined by the WASI
• Score above the cutoff on the Reciprocal Social Interactions and the Restricted, Repetitive, and Stereotyped Behaviors Domains on the ADI-R, meet criteria for PDD or autism on the ADOS, and/or meet DSM-IV criteria for Autism Spectrum Disorder according to clinician interview.

You may not qualify if…

• 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
• Severe, current psychiatric disorder (ie, current mania, severe depression, psychosis, suicidality, severe aggression)
• Long QT, as determined by baseline EKG
• Current participation in other psychotherapy
• Additional exclusion criteria for MRI scan only:
• Participants who are MRI-ineligible will be enrolled in the clinical trial portion of the study, but will not undergo the MRI scan at MIT. Exclusion criteria for MRI are:
• Presence of metal implants or other metal in the body
• History of claustrophobia or inability to tolerate MRI

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Massachusetts Institute of Technology Martinos Imaging Center — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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