Not yet taking people in ChinaNo phase

Low-dose buprenorphine skin patch for children and teens with autism

Tests a low-dose buprenorphine patch in young people with autism spectrum disorder.

Key facts

Who runs it: Peking University Sixth Hospital
Where: Beijing, ChinaSee the site
Trial code: NCT06772324
Registry title: An Exploratory Clinical Study of a Low-dose Buprenorphine Patch for the Treatment of Autism Spectrum Disorders
Status: Not yet recruiting
People taking part: 60 people, planned
Started: Jan 2025
Planned end: Sept 2026
Type of study: Interventional, 3 groups
Treatments tested: NORSPAN Buprenorphine Transdermal Patchs for Very-low dose group
NORSPAN Buprenorphine Transdermal Patchs for Lower dose group
NORSPAN Buprenorphine Transdermal Patchs for higher dose group
Record updated: 13 January 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers aged 6 to 18 with autism spectrum disorder who have moderate or greater symptom severity.

Age: 6 to 18 years
Sex: Boys and girls can join.
Disease stage: Autism spectrum disorder diagnosed by DSM-5, K-SADS-PL-C DSM-5 and CARS, with a severity score of ≥ 4 on the CGI scale.
Earlier treatment: Medicines allowed at screening must be clarified and stable. Prohibited medicines must not be used for at least 2 weeks before screening, with at least 4 weeks washout before the baseline assessment.

Main reasons for not taking part

Another mental disorder besides ADHD
Seizures in the past 6 months
Suicide risk, or alcohol or drug abuse or dependence
Heart disease not well controlled, or abnormal ECG findings
Allergy to buprenorphine

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

Sex: male/female
Age:6-18 years at the time of randomization
Clinical diagnosis in accordance with the DSM-5 diagnosis of ASD
Diagnosis of ASD using the K-SADS-PL-C DSM-5 and CARS
A severity score of ≥ 4 on the CGI scale
Subjects must be able to participate and deemed suitable for participation in the study, at the investigator's discretion, and be able to follow the study evaluation schedule
The parent or guardian agrees to accompany the subject to all clinical visits and to provide information about the subject's behavior and symptoms, and must agree to supervise the subject's compliance with protocol-specified procedures and the use of study drug doses
The parent or guardian is willing and able to give written informed consent in accordance with local requirements. When the subject is capable of making the decision to consent to participation in the study, the subject is likewise willing and able to provide written informed consent in accordance with local requirements

Who cannot take part

Neurologic/Psychiatric Disorders; Concurrent comorbidity with any other mental disorder (other than ADHD) as diagnosed by the K-SADS-PL-C DSM-5; Neurologic disorders or prior head trauma resulting in coma; Unstable or uncontrollable clinically significant psychiatric and/or neurological disorders that may interfere with safety or efficacy outcome; Unstable or uncontrolled irritability in the judgment of the investigator; Any suicide attempts in the opinion of the investigator at the time of screening that he/she is at risk for suicidal behavior or in his/her medical history; A history of seizures within the past 6 months; A history of alcohol or other substance abuse/dependence
Other exclusion criteria; Marked respiratory depression; Acute or severe bronchial asthma; Known or suspected paralytic bowel obstruction; Allergic to buprenorphine; Participation in a drug study within 30 days prior to randomization or within 5 times the half-life of the molecule to be studied, whichever is longer; or drug study; or participation in a study testing a medical device within 30 days prior to randomization, or the device is still in action. active; History of blood loss greater than 250 mL within 3 months prior to screening; Medications permitted since 4 weeks prior to screening that have NOT been clearified and stable, and medications permitted for the treatment of epilepsy since 3 months prior to screening that have NOT been clearified and stable; Usage of a prohibited medication within 2 weeks prior to the screening visit (and ensuring at least 4 weeks of washout time prior to the baseline assessment) or usage of a prohibited medication within 5 times of half-life prior to the randomization (whichever is longer)
Diseases of other organ systems; Accompanying other diseases or conditions (pulmonary, gastrointestinal, hepatic, renal, metabolic, immune system, or obesity) that may interfere or whose treatment may interfere with the conduct of the study; or where, in the opinion of the Investigator, discontinuation of the Prohibited Substance may pose an unacceptable risk to the subject; Evidence of gastrointestinal bleeding, e.g., active gastric ulcer; History of coagulopathy, bleeding disorders or blood disorders
Cardiovascular Disease; Current cardiovascular disease not effectively controlled in the opinion of the investigator; Clinically significant abnormalities (e.g., twice consecutive measurements) as confirmed by ECG at screening, including, but not limited to: QTc: ≥450 milliseconds, absence of predominant sinus rhythm, and second or third degree a-v block

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 6 and 18 years old?

Where in China

Peking University Sixth HospitalBeijing, ChinaContact: Qingjiu CaoNo longer taking part

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

Very-low dose groupTreatment being tested
Dosing will begin on Day 1, and the buprenorphine transdermal patch will be changed every 7 days, i.e., Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, and Day 57. Of these, Day 15, Day 22, Day 36, Day 43, and Day 50 will require subjects and their guardians to self-replace the patch at home. Day 1, Day 8, Day 29, and Day 57 will receive medication in the hospital. Day1 0 mg patch; all subjects receiving their medication in-hospital after completing all tests assessed at baseline; Day8, Day29 one-ninth of a 5mg patch and replaced with a 0mg patch before returning home from the test; all subjects will receive medication upon arrival at the hospital before completing relevant assessment tests; Day57 one-ninth of a 5-mg patch; all subjects will receive medication upon arrival at the hospital before completing relevant assessment tests and will be allowed to go home only after removing the used buprenorphine transdermal patch at the end of the assessment;
Treatment: NORSPAN Buprenorphine Transdermal Patchs for Very-low dose group
Lower dose groupTreatment being tested
Dosing will begin on Day 1, and the buprenorphine transdermal patch will be changed every 7 days, i.e., Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, and Day 57. Of these, Day 15, Day 22, Day 36, Day 43, and Day 50 will require subjects and their guardians to self-replace the patch at home. Day 1, 8, 29, and 57 will receive medication in the hospital. Day1 one-ninth of a 5 mg patch; all subjects receiving their medication in-hospital after completing all tests assessed at baseline; Day8, Day29 one-ninth of a 5mg patch and replaced with one-ninth of a new 5mg patch before returning home from the test; all subjects will receive medication upon arrival at the hospital before completing relevant assessment tests; Day57 one-ninth of a 5-mg patch; all subjects will receive medication upon arrival at the hospital before completing relevant assessment tests and will be allowed to go home only after removing the used buprenorphine transdermal patch at the end of the assessment;
Treatment: NORSPAN Buprenorphine Transdermal Patchs for Lower dose group
Higher dose groupTreatment being tested
Dosing will begin on Day 1, and the buprenorphine transdermal patch will be changed every 7 days, i.e., Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, and Day 57. Of these, Day 15, Day 22, Day 36, Day 43, and Day 50 will require subjects and their guardians to self-replace the patch at home. Day 1, 8, 29, and 57 will receive medication in the hospital. Day1 one-third of a 5 mg patch; all subjects receiving their medication in-hospital after completing all tests assessed at baseline; Day8, Day29 one-third of a 5mg patch wil be replaced with one-third of a new 5mg patch before returning home from the test; all subjects will receive medication upon arrival at the hospital before completing relevant assessment tests; Day57 one-third of a 5-mg patch; all subjects will receive medication upon arrival at the hospital before completing relevant assessment tests and will be allowed to go home only after removing the used buprenorphine transdermal patch at the end of the assessment;
Treatment: NORSPAN Buprenorphine Transdermal Patchs for higher dose group