Autism Research Study
Researchers at the Center for Autism and the Developing Brain (CADB) and Institute for Basic Research (IBR) are conducting a study to see if an investigational medication called propranolol can help reduce aggression, self-injury, and severe disruptive behaviors in adolescents and adults with autism spectrum disorder (ASD). Participants will need to complete 1-3 in-person visits at one of our study sites. These visits may also occur at the participant’s place of residence when needed. All other study visits will be conducted remotely over zoom.
Fast Facts
12-40 years old with a study partner
Diagnosed with Autism and have frequent and severe challenging behaviors
Compensation
Provided
Conducted in
New York. 1-3 in-person visits needed in White Plains, Staten Island, or participant's home. All other visits conducted over zoom.
Study Background
Researchers at the Center for Autism and the Developing Brain (CADB) and Institute for Basic Research (IBR) are conducting a study to see if a medication called propranolol can help reduce aggression, self-injury, and severe disruptive behaviors in adolescents and adults with autism spectrum disorder (ASD).
This study is evaluating whether a medication called propranolol may be a safe and effective option for reducing severe challenging behaviors in individuals with autism spectrum disorder.
Adolescents and adults with ASD may experience challenging behaviors such as physical aggression, self-injury, and severe agitation that can significantly impact daily functioning and quality of life. While some treatments are available, there remains a need for additional research to better understand effective and well-tolerated treatment options for these behaviors.
This study is looking to see if propranolol, a medication that has been prescribed for over 50 years for conditions such as high blood pressure, cardiac disorders, migraines, and anxiety, may help people with ASD and challenging behaviors. Although propranolol is not approved specifically for autism-related behaviors, prior research has shown potential benefits of this medication in reducing aggression. The use of propranolol in this study is considered investigational. This study will evaluate its safety and effectiveness in adolescents and adults with ASD through close medical monitoring, including regular blood pressure and heart rate assessments.
Study Background
Researchers at the Center for Autism and the Developing Brain (CADB) and Institute for Basic Research (IBR) are conducting a study to see if a medication called propranolol can help reduce aggression, self-injury, and severe disruptive behaviors in adolescents and adults with autism spectrum disorder (ASD).
This study is evaluating whether a medication called propranolol may be a safe and effective option for reducing severe challenging behaviors in individuals with autism spectrum disorder.
Adolescents and adults with ASD may experience challenging behaviors such as physical aggression, self-injury, and severe agitation that can significantly impact daily functioning and quality of life. While some treatments are available, there remains a need for additional research to better understand effective and well-tolerated treatment options for these behaviors.
This study is looking to see if propranolol, a medication that has been prescribed for over 50 years for conditions such as high blood pressure, cardiac disorders, migraines, and anxiety, may help people with ASD and challenging behaviors. Although propranolol is not approved specifically for autism-related behaviors, prior research has shown potential benefits of this medication in reducing aggression. The use of propranolol in this study is considered investigational. This study will evaluate its safety and effectiveness in adolescents and adults with ASD through close medical monitoring, including regular blood pressure and heart rate assessments.
Additional Information
This study is being conducted to determine whether propranolol may help reduce aggression, self-injury, and severe disruptive behavior in adolescents and adults with autism spectrum disorder.
You may qualify for this study if you meet the following criteria:
- 12-40 years
- Diagnosed with autism spectrum disorder (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
You may not be eligible for the study if you are currently taking propranolol, or other medications that are contraindicated with propranolol. A member of the study team will review the eligibility criteria with you and answer any questions.
If you choose to participate in this study, you will first complete a phone screening to determine eligibility. There are two phases in the study as described below. Your total participation may range from 13-25 weeks based on if you choose to complete both phases of the study:
The first 12 weeks of the study are what is called Double-Blind phase. Like flipping a coin, participants have a 50/50 chance to receive the active medication(propranolol) or a placebo pill (like a sugar pill with no effect).
The last 12 weeks of the study are what is called the Open-Label phase. This means that everyone receives propranolol.
Participants may have to complete 1–2 in-person visits at one of our study sites in White Plains, NY or Staten Island, NY, for study-related exams, such as physical examinations, electrocardiograms, medication reviews, and pregnancy testing (for females). These in-person visits can be completed in the participant’s place of residence when needed.
All other study visits will be conducted virtually via a HIPAA-compliant teleconferencing platform. A study partner will participate in weekly online check-ins with the research team, assist with behavioral questionnaires, and help measure blood pressure at home. Participants will also complete three 24-hour heart monitoring (Holter) assessments during the study. Throughout participation, the study team will closely monitor health and safety, and all procedures will be fully explained before you decide to take part.
The participant will be compensated for their time for completing the study, as well as reimbursed for study-related expenses.
There is no cost for you to participate in our research study.