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RECRUITING
NCT07091279
PHASE2

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

Sponsor: Jeremy Veenstra-vanderweele

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-01-30

Completion Date

2028-12

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

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

Locations (2)

New York State Institute for Basic Research (IBR)

Staten Island, New York, United States

Center for Autism and the Developing Brain

White Plains, New York, United States