NCT06772324

An Exploratory Clinical Study of a Low-dose Buprenorphine Patch for the Treatment of Autism Spectrum Disorders

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Peking University Sixth Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and efficacy of low-dose buprenorphine in patients with ASD by using standard ASD symptom assessment methods (e.g., SRS-2 and ABC) as well as AI-assisted analyses utilizing exploratory gaze patterns in conjunction with fMRI and electroencephalogram measurements to assess changes in brain functional status.

Detailed description

The study aims to assess the safety and efficacy of buprenorphine in patients with autism spectrum disorders (ASD) in very low, lower, and higher dose groups and to explore the sensitivity and specificity of ophthalmoscopy for evaluating the efficacy of ASD treatment. Combined neuroimaging techniques to examine the effects of buprenorphine on neurologic function in ASD. In this study, changes in functional brain status will be assessed by using standard ASD symptom assessment methods (e.g., SRS and ABC) as well as algorithms utilizing AI's exploratory gaze patterns in conjunction with functional magnetic resonance and electroencephalography imaging to evaluate changes in the functional brain state of the very low-dose group (5 mg 1/9 at follow-up only), the lower-dose group (5 mg 1/9/week) and the higher-dose group (5 mg 1/3/week) buprenorphine safety and efficacy in patients with ASD. This study will validate the results of previous studies based on humans and rodents and is expected to develop an effective drug for treating the core symptoms of ASD with significant social and economic benefits. This is a randomized, three-arm, double-blind study in male/female subjects with ASD with a treatment duration of 56 days. Items to be evaluated include efficacy on ASD symptoms, safety, Day57's buprenorphine drug concentration in plasma, and changes in oculomotor, functional magnetic resonance, and electroencephalographic data before and after treatment. The effective dose is estimated based on the results of preclinical studies of buprenorphine in ASD model mice, using a dose of one-third or one-ninth of the available 5-mg buprenorphine transdermal patch.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	NORSPAN Buprenorphine Transdermal Patchs for Very-low dose group	Very-low dose group will receive medication on arrival before completing the relevant assessment tests; the very-low dose group will be administered 1/9 of a 5mg buprenorphine transdermal patch and replaced with a 0mg patch before returning home from the examination.
DRUG	NORSPAN Buprenorphine Transdermal Patchs for Lower dose group	The lower dose group will be administered 1/9 of a 5mg buprenorphine transdermal patch.
DRUG	NORSPAN Buprenorphine Transdermal Patchs for higher dose group	The higher dose group will be administered 1/3 of a 5mg buprenorphine transdermal patch.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2025-01-13
• Last updated: 2025-01-13

Locations

1 site across 1 country: China