RECRUITING

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

Conditions

Autism Spectrum Disorder Challenging Behaviour Aggression Severe Disruptive Behaviour Disorders Self-injury autism propranolol severe disruptive behavior challenging behavior randomized clinical trial RCT high dose propranolol open label

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-09-22

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07091279

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Suvekcha Bhattachan, MA

CONTACT

914-997-5587

suvekcha.bhattachan@nyspi.columbia.edu

Alyssa Verdes, BA

CONTACT

914-997-5532

alyssa.verdes@nyspi.columbia.edu

Principal Investigator

Jeremy Veenstra-VanderWeele, MD

PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Eric London, MD

PRINCIPAL_INVESTIGATOR

New York State Institute for Basic Research (IBR)

Study Locations (Sites)

New York State Institute for Basic Research (IBR)

Staten Island, New York, 10314

United States

Center for Autism and the Developing Brain

White Plains, New York, 10605

United States

Collaborators and Investigators

Sponsor: Jeremy Veenstra-vanderweele

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-22

Study Completion Date2028-12

Study Record Updates

Study Start Date2025-09-22

Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

autism
autism spectrum disorder
propranolol
severe disruptive behavior
aggression
challenging behavior
self-injury
randomized clinical trial
RCT
high dose propranolol
open label

Additional Relevant MeSH Terms

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