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

NCT06772324 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-01-13

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Ping An-Shionogi Co., Ltd.

    collaborator UNKNOWN

  • Peking University Sixth Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2026-08-31
Completion
2026-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06772324 on ClinicalTrials.gov