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

Part of paid clinical trials in Staten Island, New York.

Sponsor
Jeremy Veenstra-vanderweele
Study ID
NCT07091279
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Propranolol — DRUG
    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 — DRUG
    Placebo for Propranolol

Study Details

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.

Key Dates

Start date
Jan 30, 2026
Status verified
Mar 2026
Primary completion
Nov 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (2)

FacilityCityStateZIPSite coordinators
New York State Institute for Basic Research (IBR)Staten IslandNew York10314
Suvekcha Bhattachan, MA
[email protected]
914-997-5587
Alyssa Verdes, BA
[email protected]
914-997-5532
Eric London, MD (PRINCIPAL_INVESTIGATOR)
Jiyeon Helen Yoo, PhD (SUB_INVESTIGATOR)
Center for Autism and the Developing BrainWhite PlainsNew York10605
Suvekcha Bhattachan, MA
[email protected]
914-997-5587
Alyssa Verdes, BA
[email protected]
914-997-5532
Jeremy Veenstra-VanderWeele, MD (PRINCIPAL_INVESTIGATOR)
Pankhuree Vandana, MD (SUB_INVESTIGATOR)
Karen Tang, PhD (SUB_INVESTIGATOR)

Find similar trials in Staten Island, NY

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
New York State Institute for Basic Research (IBR)· Staten Island, NYCenter for Autism and the Developing Brain· White Plains, NY

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