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Medication Research on Severe Challenging Behaviors

Study Flyer:
Eligibility Criteria:
WHO:

Researchers: Jeremy Veenstra-VanderWeele, MD (PI) and Eric London (Co-PI)
Institution: Center for Autism and the Developing Brain (CADB), and, Institute for Basic Research (IBR)

WHAT:

Medication Study for Severe Challenging Behaviors

WHERE:

Initial 2-3 visits at CADB, White Plains, NY, or IBR, Staten Island, NY. Other visits online (zoom).

RECRUITMENT ENDS:

2028-11-01

Interested?

If you have any questions or need further information about the study, please feel free to contact us at cadbmedicine@cumc.columbia.edu or 914-997-5587.

What's the study about?

The purpose of this study is to see if a medication called propranolol may reduce severe challenging behaviors in adolescents and adults with autism spectrum disorder (ASD).

Currently, propranolol is used to treat cardiovascular conditions, migraines, tremors, and anxiety. We want to see if this medication may help adolescents and adults with ASD who have frequent and severe challenging behaviors that impact their quality of life.

A previous, smaller study showed safety and potential benefits of propranolol in reducing severe challenging behaviors in ASD. The use of propranolol in this study is considered investigational.

Who can participate?

Participants must:
– Be between 12-40 years of age at time of consenting
– Have a diagnosis of ASD
– Have frequent and severe challenging behaviors (e.g., physical aggression, self-injury, agitation)
– Have a study partner (e.g., parent, legal guardian, spouse, roommate) also willing to participate in the study

Additional requirements to participate must also be met. Our staff at the study site will explain the complete list of requirements.

What will participants be doing?

Participation in this study may last up to 26 weeks and will include up to 3 in-person visits to one of our study sites in White Plains, NY or Staten Island, NY. These in-person visits may be completed in the participant’s place of residence if needed. All other study visits will be completed online via telehealth platform.
The study partner must complete weekly online telehealth visits with the study team to check in on the participant’s health and complete questionnaires related to the participant’s behaviors.

Study procedures also include medical assessments, vital checks, electrocardiograms (EKG), Holter monitor, and urine collection when needed.

Why is this important?

We hope that the results from this study will provide a safe and effective treatment option for individuals with ASD who experience severe challenging behaviors, helping to improve their well-being and quality of life, particularly as current treatment options remain limited for this population. Currently, few medications are specifically approved for these challenges, and existing options often have unwanted side effects. Better treatment for individuals with ASD who experience severe challenging behaviors is therefore urgently needed.

Research Study Website