The goal of this clinical trial is to learn if propranolol can help reduce challenging behaviors associated with Autism Spectrum Disorder, including aggression, self-injury, and severe disruptive behaviors. Participants will be randomly assigned to receive either propranolol or a placebo (a look-alike substance that contains no drug) daily for 12 weeks. After the 12 weeks, all participants will have the opportunity to receive propranolol for an additional 12 weeks.
Age between 12-40 years.
Clinical best-estimate diagnosis of autism spectrum disorder
Occurrence of severe challenging behaviors, such as aggression, self-injury, and/or severely disruptive or destructive behavior, leading to safety concerns or serious impact of the quality of life, at least weekly over the past 2 months before screening.
Score in the ASD range on the Autism Diagnostic Observation Schedule conducted at the time of study entry or in the past 5 years
Those who are unable to provide informed consent and have no parent/guardian/legally authorized representative to provide informed consent for study enrollment
Change in psychotropic medication or behavioral intervention (except when caused by vocational, habilitation, or school schedule) within two months before randomization.
Asthma or history of any disorder involving bronchoconstriction in the past 5 years.
Cardiovascular history in which the use of propranolol at high doses would be contraindicated, as determined by consulting cardiologist (such as AV block, sick sinus syndrome, valvular pathologies, cardiomyopathies, or vascular disease).
Jeremy Veenstra-vanderweele
Lead sponsor
New York State Psychiatric Institute
Sponsor institution
United States Department of Defense
Collaborator
New York State Institute for Basic Research
Collaborator