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临床试验/NCT05100563
NCT05100563已完成不适用

Participant(s) With Autism and High Pain Tolerance Treated With High Dose Naltrexone

State University of New York - Upstate Medical University1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年10月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
1
主要终点
improvement of social responsiveness scale (SRS) and social communication questionnaire (SCQ)

研究概览

简要总结

High dose naltrexone with response gauged by pain tolerance as measured by the cold pressor test may help treat autism.

详细描述

Clinical Trial: Cause and Treatment of High Opioid Tone Autism Key Words: autism, neurobiological systems engineering, opioid tone, cold pressor time, clinical trial Abstract Introduction: Neurobiological systems engineering models are useful for treating patients. We show a model of "high opioid tone" autism and present a hypothesis about how autism is caused by administration of opioids during childbirth.

Main Symptoms: Clinical diagnosis of autism in a 25 year old man was confirmed by a Social Responsiveness Scale (SRS) self - rating of 79, severe, and a Social Communications Questionnaire (SCQ - 2) by the patient's father scoring 27. Cold pressor time is a measure of pain tolerance obtained by having the subject submerge their normal forearm in a painful ice water bath. Cold pressor time (CPT) was 190 seconds - unusually long, consonant with the high pain tolerance of autism.

Therapeutic Intervention and Outcome Measure:

Primary Outcome Measure is the Cold Pressor Time (CPT). At naltrexone 50 mg/day CPT fell to 28, repeat 39 seconds.

Secondary outcome measures are Social Responsiveness Scale (SRS) and Social Communications Questionnaire (SCQ-2). SRS fell to 54 and SCQ - 2 to 9; both non - significant for autism.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
12 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of autism -

排除标准

  • Lack of ability to give informed consent

结局指标

主要结局

improvement of social responsiveness scale (SRS) and social communication questionnaire (SCQ)

时间窗: After two weeks at optimal naltrexone dose

evaluation by patient at baseline and follow up of SRS and his father SCQ

次要结局

  • Cold Pressor Time(After a week on optimized naltrexone dose with repeat two weeks later)

研究者

发起方
State University of New York - Upstate Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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