NCT04047355

Propranolol for Challenging Behaviors in Autism

A Pilot/Feasibility Study of the Use of High Dose Propranolol to Treat Severe and Chronic Challenging Behaviors in Adolescents and Adults With Autism Spectrum Disorders

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 12 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double blind, placebo controlled crossover study. A complete cardiac exam will be conducted by the pediatric cardiology team at the Robert Wood Johnson Medical School. All participants will remain on their existing, pre-study medication throughout all phases of the study. Once admitted to the study, a baseline period will begin. During the baseline period, cognitive and adaptive information will be collected. The participant will then be randomly assigned to propranolol (Phase A) or placebo (Phase B). The titration schedule will be flexible and the dose can be held steady for an extended period. Dose reduction to manage side effects are allowed at any time. Each week the family will complete behavioral forms online and meet with the study psychiatrist via telemedicine. Following the initial Phase (A or B), participants will undergo a washout period (whether propranolol or placebo). Then, they will crossover to the other Phase (A or B). Upon completion of the crossover phase, the study blind will be broken. The participants then had the option of enrolling in an open label study.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-11
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2019-08-06
• Last updated: 2025-06-04
• Results posted: 2025-06-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study