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Propranolol for Challenging Behaviors in Autism

This study is testing if propranolol can help reduce challenging behaviors like aggression, self-injury, and severe disruptive behaviors in adolescents and adults with Autism Spectrum Disorder (ASD). Participants, aged 12 to 40 years, will be randomly assigned to receive either propranolol or a placebo (an inactive substance) daily for 12 weeks. The main goal is to see how safe propranolol is, looking at things like changes in blood pressure and heart rate. After the initial 12 weeks, all participants will have the option to receive propranolol for an additional 12 weeks. The study aims to enroll 60 participants, but its current recruitment status is unclear.

Study design
This is an interventional study where participants are randomly assigned to receive either propranolol or a placebo. It plans to enroll 60 participants.
What's involved
You would take study medication daily for 12 weeks, with the dose gradually increasing over the first 8 weeks. After this, you may have the option to continue receiving propranolol for another 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Safety concerns and side effects will be measured from the beginning of the study through the end of the 12-week treatment phase.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07091279

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

Recruiting
PHASE2Ages 12–40InterventionalTreatment
Jeremy Veenstra-vanderweele
~60 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:PropranololPlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of safety concerns and side effects associated with high-dose propranolol, including changes in blood pressure, pulse, and occurrence of dysrhythmias.
Measured over From baseline through end of treatment phase at 12 weeks

Conditions

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

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Autism Spectrum Disorder

NCT07091279

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Center for Autism and the Developing Brain

    White Plains, New Yorkstudy coordinator listed

    Recruiting

  • New York State Institute for Basic Research (IBR)

    Staten Island, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jeremy Veenstra-VanderWeele, MD · PRINCIPAL_INVESTIGATOR · New York State Psychiatric Institute
  • Eric London, MD · PRINCIPAL_INVESTIGATOR · New York State Institute for Basic Research (IBR)

Who to contact

Suvekcha Bhattachan, MA
[email protected]
914-997-5587
Email the study team

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Eligibility criteria

Inclusion

Age between 12-40 years.
Clinical best-estimate diagnosis of autism spectrum disorder
Occurrence of severe challenging behaviors, such as aggression, self-injury, and/or severely disruptive or destructive behavior, leading to safety concerns or serious impact of the quality of life, at least weekly over the past 2 months before screening.
Score in the ASD range on the Autism Diagnostic Observation Schedule conducted at the time of study entry or in the past 5 years
Clinical Global Impression Severity scale (CGI-S) score of 4 or above at Baseline
Aberrant Behavior Checklist-2 Irritability/Agitation Subscale Score of 18 or above at Screening.
A resting pulse of greater than 60 and a resting blood pressure of greater than 100/60.
Participant must have a designated study partner who spends a minimum of 5 hours/week with the participant, and can, in the opinion of the investigator, provide a reliable report on the participant's behaviors, symptoms, and complete or supervise at-home safety monitoring and other assessments required during the study
Participants of childbearing potential who are sexually active must agree to practice effective contraception from time of screening through 30 days after their last dose of study drug. Effective contraception is the use of two methods of contraception: hormonal contraceptives or intrauterine device and barrier (i.e., condoms, diaphragm, or cervical cap).
Participant must be able to fully swallow study medication capsule.
English must be primary language for participant. Study partner must be able to consent in English and complete study related form in English.

Exclusion

Those who are unable to provide informed consent and have no parent/guardian/legally authorized representative to provide informed consent for study enrollment
Change in psychotropic medication or behavioral intervention (except when caused by vocational, habilitation, or school schedule) within two months before randomization.
Asthma or history of any disorder involving bronchoconstriction in the past 5 years.
Cardiovascular history in which the use of propranolol at high doses would be contraindicated, as determined by consulting cardiologist (such as AV block, sick sinus syndrome, valvular pathologies, cardiomyopathies, or vascular disease).
Uncontrolled seizure disorder (a seizure within the past year and/or changes in seizure medication in the previous six months).
Diabetes mellitus
History of lactose intolerance that requires the potential participant to abstain from all dairy products or to take lactase supplements.
Medical history of renal or hepatic impairment.
Medical history of hypoglycemia
Inability to provide blood testing when there is a medical indication for blood testing to allow clinical safety determination by the study safety physician
Depressive episode currently or within the previous six months
History of allergy or adverse reaction to propranolol or another beta-blocker
Current use of any of the following: propafenone, quinidine, amiodarone, lidocaine, digitalis glycosides, calcium channel blockers, ACE inhibitors, clonidine, alpha blockers, reserpine, inotropic agents (epinephrine), isoproterenol and dobutamine, nonsteroidal anti-inflammatory drugs (indomethacin), antidepressants (MAO inhibitors, tricyclics), anesthetic agents (methoxyflurane, trichloroethylene), warfarin, neuroleptics (haloperidol), thyroxine, alcohol
Any other medical disorder or medication which would contraindicate the use of propranolol.
Is judged to be inappropriate for the study for any reason by the Investigator
Has recently participated in another investigational medication study or device study within last 3 months
Participant is unable to complete blood pressure or ECG safety assessments
If female, is pregnant or breastfeeding.

What this trial measures

  • Incidence of safety concerns and side effects associated with high-dose propranolol, including changes in blood pressure, pulse, and occurrence of dysrhythmias.From baseline through end of treatment phase at 12 weeks

    Any participant reported side effects or adverse events will be monitored through weekly medical monitoring visits with the study safety physician. Participants will complete blinded home monitoring of blood pressure and pulse on the first three days each dosing week (baseline through end of treatment phase at 12 weeks), and pre- and post-intervention Holter monitoring will be completed for dysrhythmias (at screening and week 6)