Actively Recruiting
Propranolol for Aggression, Self-Injury, and Severe Disruptive Behavior in Adolescents and Adults With Autism
Led by Jeremy Veenstra-vanderweele · Updated on 2026-03-30
60
Participants Needed
2
Research Sites
148 weeks
Total Duration
On this page
Sponsors
J
Jeremy Veenstra-vanderweele
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Propranolol for Aggression, Self-Injury, and Severe Disruptive Behavior in Adolescents and Adults With Autism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 40 years
- Clinical diagnosis of Autism Spectrum Disorder
- Severe challenging behaviors such as aggression, self-injury, or severe disruptive behavior occurring at least weekly over the past 2 months
- Score in the ASD range on the Autism Diagnostic Observation Schedule at study entry or within the past 5 years
- Clinical Global Impression Severity score of 4 or above at baseline
- Aberrant Behavior Checklist-2 Irritability/Agitation Subscale score of 18 or above at screening
- Resting pulse greater than 60 and resting blood pressure greater than 100/60
- Has a designated study partner spending at least 5 hours per week with the participant to provide reliable behavior reports and safety monitoring
- Participants of childbearing potential who are sexually active agree to use effective contraception from screening through 30 days after last study drug dose
- Participant can fully swallow study medication capsules
- English is the primary language for the participant, and the study partner can consent and complete study forms in English
You will not qualify if you...
- Unable to provide informed consent and no parent/guardian/legal representative available to consent
- Change in psychotropic medication or behavioral intervention within 2 months before randomization (except for vocational, habilitation, or school schedule changes)
- Asthma or history of bronchoconstriction disorders in the past 5 years
- Cardiovascular conditions contraindicating high-dose propranolol use as determined by a cardiologist
- Uncontrolled seizure disorder (seizure within past year or medication changes in past 6 months)
- Diabetes mellitus
- History of lactose intolerance requiring avoidance of dairy or lactase supplements
- Renal or hepatic impairment
- History of hypoglycemia
- Unable to provide blood testing when medically indicated for safety
- Current or recent depressive episode within past 6 months
- Allergy or adverse reaction to propranolol or other beta-blockers
- Current use of certain medications including propafenone, quinidine, amiodarone, lidocaine, digitalis glycosides, calcium channel blockers, ACE inhibitors, clonidine, alpha blockers, reserpine, epinephrine, isoproterenol, dobutamine, indomethacin, MAO inhibitors, tricyclic antidepressants, methoxyflurane, trichloroethylene, warfarin, haloperidol, thyroxine, or alcohol
- Any other medical condition or medication contraindicating propranolol
- Judged inappropriate for the study by the investigator
- Participation in another investigational medication or device study within the last 3 months
- Unable to complete blood pressure or ECG safety assessments
- Pregnant or breastfeeding if female
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
New York State Institute for Basic Research (IBR)
Staten Island, New York, United States, 10314
Actively Recruiting
2
Center for Autism and the Developing Brain
White Plains, New York, United States, 10605
Actively Recruiting
Research Team
S
Suvekcha Bhattachan, MA
CONTACT
A
Alyssa Verdes, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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