NCT07091279

Propranolol for Aggression, Self-Injury, and Severe Disruptive Behavior in Adolescents and Adults With Autism

Randomized Controlled Trial of Propranolol for Aggression, Self-Injury, and Severe Disruptive Behavior in Adolescents and Adults With Autism

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jeremy Veenstra-vanderweele · Academic / Other
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study will evaluate the efficacy and safety of high dose propranolol in 60 male and female participants between the ages of 12 and 40 years who have a diagnosis of Autism Spectrum Disorder (ASD) and experience serious challenging behaviors. Participants must meet severity criteria, defined as a Clinical Global Impression Severity (CGI-S) score of 4 or higher and an Aberrant Behavior Checklist-2 Irritability/Agitation (ABC-I/A) score greater than 18. Participants will be randomly assigned to receive either propranolol or a placebo. Over the first 8 weeks, participants will gradually increase their study medication following a set schedule to find the highest dose they can tolerate (up to a maximum of 200 mg three times daily). This will be followed by 4 weeks at a steady dose. After completing the 12-week randomized phase, participants will be offered the option to learn their group assignment (propranolol or placebo) and continue into a 12-week open-label extension, where all participants will receive propranolol.

Conditions

• Autism Spectrum Disorder
• Challenging Behaviour
• Aggression
• Severe Disruptive Behaviour Disorders
• Self-injury

Interventions

Type	Name	Description
DRUG	Propranolol	Propranolol, oral, titrated in weekly increments from 10 mg TID to a maximum of 200 mg TID (total daily dose: 30 mg to 600 mg at 8 weeks), based on tolerability. Participants will continue at the highest tolerated dose for additional 4 weeks. Target doses: 10 mg, 40 mg, 80 mg, 120 mg, 160 mg, 200 mg TID.
DRUG	Placebo	Placebo for Propranolol

Timeline

• Start date: 2026-01-30
• Primary completion: 2028-11-01
• Completion: 2028-12-01
• First posted: 2025-07-29
• Last updated: 2026-03-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study