Autism Spectrum DisorderPhase 2NCT07091279
Propranolol for Aggression, Self-Injury, and Severe Disruptive Behavior in Adolescents and Adults With Autism
A Phase 2 study testing Propranolol in people with Autism Spectrum Disorder and Challenging Behaviour, run by Jeremy Veenstra-vanderweele at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Autism Spectrum Disorder, Challenging Behaviour, Aggression
- What is being tested?
- Propranolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jan 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
New York State Institute for Basic Research (IBR)
Staten Island, New York, 10314
Suvekcha Bhattachan, MA, 914-997-5587, suvekcha.bhattachan@nyspi.columbia.edu
Alyssa Verdes, BA, 914-997-5532, alyssa.verdes@nyspi.columbia.edu
- Recruiting
Center for Autism and the Developing Brain
White Plains, New York, 10605
Suvekcha Bhattachan, MA, 914-997-5587, suvekcha.bhattachan@nyspi.columbia.edu
Zahra Raza, BS, 914-997-5532, zahra.raza@nyspi.columbia.edu
About this study
Official title: Randomized Controlled Trial of Propranolol for Aggression, Self-Injury, and Severe Disruptive Behavior in Adolescents and Adults With Autism
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.
Read the detailed description
The study will evaluate the efficacy and safety of high dose propranolol in 60 male and female participants between the ages of 12 and 40 years who have a diagnosis of Autism Spectrum Disorder (ASD) and experience serious challenging behaviors. Participants must meet severity criteria, defined as a Clinical Global Impression Severity (CGI-S) score of 4 or higher and an Aberrant Behavior Checklist-2 Irritability/Agitation (ABC-I/A) score greater than 18. Participants will be randomly assigned to receive either propranolol or a placebo. Over the first 8 weeks, participants will gradually increase their study medication following a set schedule to find the highest dose they can tolerate (up to a maximum of 200 mg three times daily). This will be followed by 4 weeks at a steady dose. After completing the 12-week randomized phase, participants will be offered the option to learn their group assignment (propranolol or placebo) and continue into a 12-week open-label extension, where all participants will receive propranolol.
- Conditions
- Autism Spectrum Disorder, Challenging Behaviour, Aggression, Severe Disruptive Behaviour Disorders, Self-injury
- Being tested
- Propranolol, Placebo
- Keywords
- autism, autism spectrum disorder, propranolol, severe disruptive behavior, aggression, challenging behavior, self-injury, randomized clinical trial, RCT, high dose propranolol, open label
- Medical subject headings
- Autism Spectrum Disorder, Aggression, Self-Injurious Behavior, Autistic Disorder, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
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.
PlaceboDrug
Placebo for Propranolol
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Experimental | 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. Receives: Drug: Propranolol |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of safety concerns and side effects associated with high-dose propranolol, including changes in blood pressure, pulse, and occurrence of dysrhythmias.
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)
Measured: From baseline through end of treatment phase at 12 weeks
Secondary outcomes (1)
Evaluate propranolol for the treatment of severe behaviors in autistic adolescents and adults
Assessed using the Aberrant Behavior Checklist-Community (ABC-C) Irritability/Agitation Subscale. The ABC-C is a global behavior checklist that measures drug and other treatment effects in people with developmental disabilities. It is made up of five subscales, including Irritability, Lethargy, Inappropriate Speech, Hyperactivity, and Stereotypy based on 58 items that describe various behavioral problems.
The Irritability/Agitation Subscale (15-item questionnaire) will serve as the primary dependent measure. Each item is rated on a 4-point Likert scale, ranging from 0 (not a problem) to 3 (severe problem). The scores will range from minimum value of 0 to maximum value of 45, with higher score indicating worse outcome. The scale will be rated every 2 weeks from baseline to end of treatment phase.
Measured: Every 2 weeks from baseline through the end of the treatment phase at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start30 Jan 2026
- Primary completionNov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeremy Veenstra-vanderweele
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, New York State Institute for Basic Research
- Responsible party
- Sponsor-investigator, Jeremy Veenstra-vanderweele, New York State Psychiatric Institute
- Investigators
- Jeremy Veenstra-VanderWeele, MD, Principal investigator, New York State Psychiatric InstituteEric London, MD, Principal investigator, New York State Institute for Basic Research (IBR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091279
- Sponsor's protocol ID
- NYSPI2024-50
- Other IDs
- AR230160
- Status last verified
- Aug 2026
- First submitted
- 7 Jul 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this study may be submitted to the NIMH Data Archive (NDA). NDA is a computer system run by the National Institute of Mental Health (NIMH) that allows researchers to collect and share information with each other. During and after the study, the researchers will send health and behavioral information about the subject, in some cases, the subject's genetic information, to NDA. However, before they send it to NDA, names, addresses, phone numbers, and other identifiable information will be removed, and replaced that information with a code number called a Global Unique Identifier (GUID). Other researchers nationwide can then file an application with the National Institutes of Health to obtain access to this study data for research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Propranolol for Aggression, Self-Injury, and Severe Disruptive Behavior in Adolescents and Adults With Autism
- ClinicalTrials.gov ID
- NCT07091279
- Acronym / sponsor ID
- NYSPI2024-50
- Conditions
- Autism Spectrum Disorder, Challenging Behaviour, Aggression, Severe Disruptive Behaviour Disorders, Self-injury
- Keywords
- autism, autism spectrum disorder, propranolol, severe disruptive behavior, aggression, challenging behavior, self-injury, randomized clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jeremy Veenstra-vanderweeleUniversity, hospital or other
- Collaborators
- United States Department of Defense, New York State Institute for Basic Research
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will evaluate the efficacy and safety of high dose propranolol in 60 male and female participants between the ages of 12 and 40 years who have a diagnosis of Autism Spectrum Disorder (ASD) and experience serious challenging behaviors. Participants must meet severity criteria, defined as a Clinical Global Impression Severity (CGI-S) score of 4 or higher and an Aberrant Behavior Checklist-2 Irritability/Agitation (ABC-I/A) score greater than 18. Participants will be randomly assigned to receive either propranolol or a placebo. Over the first 8 weeks, participants will gradually increase their study medication following a set schedule to find the highest dose they can tolerate (up to a maximum of 200 mg three times daily). This will be followed by 4 weeks at a steady dose. After completing the 12-week randomized phase, participants will be offered the option to learn their group assignment (propranolol or placebo) and continue into a 12-week open-label extension, where all participants will receive propranolol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Experimental | Drug: PropranololPropranolol, 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 | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololPropranolol, 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 | Propranolol |
| PlaceboPlacebo for Propranolol | Drug | Placebo |
Primary outcome
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)
1 secondary outcome
Evaluate propranolol for the treatment of severe behaviors in autistic adolescents and adults
Time frame: Every 2 weeks from baseline through the end of the treatment phase at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. Data from this study may be submitted to the NIMH Data Archive (NDA). NDA is a computer system run by the National Institute of Mental Health (NIMH) that allows researchers to collect and share information with each other. During and after the study, the researchers will send health and behavioral information about the subject, in some cases, the subject's genetic information, to NDA. However, before they send it to NDA, names, addresses, phone numbers, and other identifiable information will be removed, and replaced that information with a code number called a Global Unique Identifier (GUID). Other researchers nationwide can then file an application with the National Institutes of Health to obtain access to this study data for research purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeremy Veenstra-VanderWeele, MD principal investigator
New York State Psychiatric Institute
Eric London, MD principal investigator
New York State Institute for Basic Research (IBR)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol in people with Autism Spectrum Disorder and Challenging Behaviour, run by Jeremy Veenstra-vanderweele at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suvekcha Bhattachan, MA (914-997-5587, suvekcha.bhattachan@nyspi.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.