Propranolol for Challenging Behaviors in Autism

Summary

Severe challenging behaviors such as aggression and self-injury can cause significant morbidity and decrease the quality of life for individuals with Autism Spectrum Disorders (ASD). There are only two medications (Risperdal and Abilify) rigorously studied and FDA-approved for the treatment of irritability in individuals with ASD. These medications are not always successful and have many short and long-term side effects. Well-designed studies demonstrating efficacy and safety of alternative medication treatment choices are needed. There is preliminary evidence that high-dose propranolol can be effective in individuals with ASD who display severe aggression and have not responded to antipsychotics or mood stabilizers. Concerns regarding the safety of high dose propranolol have limited its clinical application. Well-designed clinical trials demonstrating the efficacy and safety of high dose propranolol will have significant effects on clinical practice and improve the physical and behavioral quality of life for an underserved subset of individuals with ASD.

This study will pilot the safety and efficacy of high dose propranolol. The investigators will randomly assign participants to either propranolol or to placebo later crossing each participant over to the other group. As propranolol can cause changes in blood pressure and heart function, each participant will complete initial comprehensive testing to monitor cardiac safety throughout the study. The investigators will be utilizing telemedicine and computer based telemetry to minimize the burden of office visits on the individual and family.

Conditions

• Autism Spectrum Disorder
• Developmental Disability
• Aggression
• Self-Injurious Behavior
• Challenging Behavior

Interventions

DRUG

Propranolol

Propranolol is a beta-blocker used to treat high blood pressure, irregular heartbeats, and tremors. It is used after a heart attack and to prevent migraine headaches and chest pain. It is also used off-label for anxiety and PTSD.

Sponsors & Collaborators

• New Jersey Governor's Council for Medical Research and Treatment of Autism

  collaborator UNKNOWN

• New York State Institute for Basic Research

  collaborator OTHER_GOV

• Rutgers, The State University of New Jersey

  lead OTHER

Principal Investigators

• Barbie Zimmerman-Bier, M.D. · Rutgers, The State University of New Jersey

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

12 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-11

Primary Completion

2023-09-30

Completion

2023-09-30

FDA Drug

Yes

Countries

• United States

Study Locations