Trial · NCT06772324
An Exploratory Clinical Study of a Low-dose Buprenorphine Patch for the Treatment of Autism Spectrum Disorders
NCT06772324, Not applicable, Not yet recruiting, Peking University Sixth Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. An Exploratory Clinical Study of a Low-dose Buprenorphine Patch for the Treatment of Autism Spectrum Disorders. Trials, record NCT06772324. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06772324
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Exploratory Clinical Study of a Low-dose Buprenorphine Patch for the Treatment of Autism Spectrum Disorders
- NCT number
- NCT06772324
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Peking University Sixth Hospital
- Conditions
- Autism Spectrum Disorder
- Interventions
- 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
- First posted
- 2025-01-13
- Last updated
- 2025-01-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Social Responsiveness Scale (SRS) | screening period, Day 1, Day 29, Day 57. | It is a screening tool for the diagnosis and assessment of autism in children aged 4-18 years that recognizes the presence of ASD-related social impairments and quantifies their severity. It identifies ASD-related social impairments and quantifies their severity. The scale consists of 65 questions categorized as Social Self-Consciousness, Social Cognition, Social Communication, and Social Self-Expression. The scale consists of 65 questions divided into five dimensions: social awareness, social cognition, social communication, social motivation, and autistic behavior. There are a total of 65 questions, with a minimum score of 1 and a maximum score of 4 for each question, with a total score range of 65-260. The higher the score, the more significant the condition. |
| Primary | Autism Behavior Checklist （ABC） | Day 1, Day 29, Day 57. | It is a behavioral assessment tool for children with autism and is primarily used to assess the outcome of patients with mental retardation and autism. The scale consists of 58 items divided into 5 factors: emotional lability/self-injurious aggression (15 items), social withdrawal/stagnation (16 items), stereotypic behavior (7 items), hyperactivity (16 items), and inappropriate speech (4 items). There are a total of 58 questions, each with a minimum score of 0 and a maximum score of 3, with a total score range of 0-174. The higher the score, the more significant the condition. |
| Secondary | Clinical Global Impression (CGI) | screening period, Day 1, Day 29, Day 57. | It is an overall rating scale that is applicable to any psychiatric treatment and research subject. The comprehensive score is based on the two dimensions of efficacy and adverse reactions. The most effective and least adverse reaction score is 1 point, while the least effective and most adverse reaction score is 16 points. The score range is 1-16. |
| Secondary | Treatment Emergent Symptom Scale (TESS) | Day8, Day 29, Day 57. | It is a medication safety evaluation tool used by psychiatrists to assess side effects in patients taking psychotropic medications. There are a total of 29 questions, each with three dimensions: severity, relationship with medication, and treatment. The score range for severity is 0-4, with higher scores indicating greater severity. The score range for the relationship with drugs is 0-4, and the higher the score, the greater the relationship with drugs. The processing range is 0-6, and the higher the score, the greater the degree of processing. |
| Secondary | Patient Global Impression (PGI) | Day 1, Day 29, Day 57. | There are two questions in total, namely severity and overall evaluation of efficacy. The score range for severity is 0-4, with higher scores indicating greater severity. The score range for the overall efficacy evaluation is 0-7, with higher scores indicating greater deterioration of the condition. |
| Secondary | Eye Tracking Test | screening period, Day 1, Day8, Day 29, Day 57. | Subjects will be seated in front of a monitor equipped with eye-tracking equipment. The equipment will be adjusted according to the subject's actual condition before the formal start. After commissioning, a 1-2 minute video will be played and eye movement data will be collected during the video. The eye movement data will be analyzed by quantifying the ratio of the length of time the patient looks at the face of the person appearing in the video to the length of time he/she looks at the geometric figure, the length of time he/she looks at the eye region of the person, and so on. |
| Secondary | functional magnetic resonance imaging (fMRI) | screening period, Day 57. | Includes resting-state fMRI data, DTI data, and ASL data, collected during the screening period and at visit 5, respectively. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06772324
GET https://conductscience.org/api/trials/v1/NCT06772324/registered