NCT07091279 · Jeremy Veenstra-vanderweele
Propranolol for Aggression, Self-Injury, and Severe Disruptive Behavior in Adolescents and Adults With Autism
What this study 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.
View original scientific description
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.
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
Primary outcome measures
Incidence of safety concerns and side effects associated with high-dose propranolol, including changes in blood pressure, pulse, and occurrence of dysrhythmias.
Time frame: 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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Staten Island, New York
- White Plains, New York
Collaborators
United States Department of Defense, New York State Institute for Basic Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 1, 2026 · Source of record for eligibility and locations