Recruiting
Phase 2

Propranolol

Sponsor:

Jeremy Veenstra-vanderweele

Code:

NCT07091279

Conditions

Autism Spectrum Disorder

Challenging Behaviour

Aggression

Severe Disruptive Behaviour Disorders

Self-injury

Eligibility Criteria

Sex: All

Age: 12 - 40

Healthy Volunteers: Not accepted

Interventions

Propranolol

Placebo

Study Details

Brief 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.

Conditions

Autism Spectrum Disorder

Challenging Behaviour

Aggression

Severe Disruptive Behaviour Disorders

Self-injury

Study ID

NCT07091279

Start date

Jan 30, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 40

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Propranolol

Propranolol, oral, starting at 30 mg/day (10 mg TID), titrated weekly based on tolerability to a maximum of 600 mg/day (200 mg TID) by Week 8. Participants will remain on their highest tolerated dose for an additional 4 weeks.

placebo comparator: Placebo

Participants will receive oral placebo tablets matched in appearance and dosing schedule to Propranolol. The dose will be titrated weekly in parallel with the experimental arm, and participants will remain on the highest tolerated dose for an additional 4 weeks.

Interventions

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.

Placebo

Placebo for Propranolol

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Suvekcha Bhattachan, MA

914-997-5587suvekcha.bhattachan@nyspi.columbia.edu

Alyssa Verdes, BA

914-997-5532alyssa.verdes@nyspi.columbia.edu

Locations

New York State Institute for Basic Research (IBR)

Recruiting

Staten Island, New York, United States, 10314

Contacts

Suvekcha Bhattachan, MA

914-997-5587suvekcha.bhattachan@nyspi.columbia.edu

Alyssa Verdes, BA

914-997-5532alyssa.verdes@nyspi.columbia.edu

Principal Investigator:

Eric London, MD

Center for Autism and the Developing Brain

Recruiting

White Plains, New York, United States, 10605

Contacts

Suvekcha Bhattachan, MA

914-997-5587suvekcha.bhattachan@nyspi.columbia.edu

Zahra Raza, BS

914-997-5532zahra.raza@nyspi.columbia.edu

Principal Investigator:

Jeremy Veenstra-VanderWeele, MD

More Information

Sponsor

Jeremy Veenstra-vanderweele

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Jeremy Veenstra-vanderweele on 2026-09-01.