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

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Autism Spectrum Disorders

Treatments: Drug: Oxytocin; Behavioral: Stress management/relaxation training; Behavioral: Social Skills focused CBT; Drug: placebo drug

Study type: Interventional

Funder types: Other

Identifiers

NCT01914939

W81XWH-12-1-0543

Clinical Trial Award (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 4 patient groups, including a placebo group

Social Skills Focused CBT

Experimental group

Description:

Twelve weekly 60-minute sessions of social skills focused CBT

Treatment:

Behavioral: Social Skills focused CBT

Stress Management/Relaxation Training

Active Comparator group

Description:

Twelve weekly 60-minute sessions of stress management training

Treatment:

Behavioral: Stress management/relaxation training

Oxytocin

Experimental group

Description:

Intranasal administration of 24 IU of oxytocin

Treatment:

Drug: Oxytocin

placebo drug

Placebo Comparator group

Description:

Intranasal placebo drug

Treatment:

Drug: placebo drug