Participant(s) With Autism and High Pain Tolerance Treated With High Dose Naltrexone
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|ClinicalTrials.gov Identifier: NCT05100563|
Recruitment Status : Completed
First Posted : October 29, 2021
Last Update Posted : May 11, 2022
|Condition or disease||Intervention/treatment|
|Autism Spectrum Disorder||Drug: 50 mg naltrexone|
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.
Change in relatedness was experienced ambivalently, understood as feelings never before experienced - causing pain. Non - compliance with naltrexone was followed by cutting open his palm and drinking alcoholically. Transference focused psychotherapy has helped him remain naltrexone - compliant while he works on issues of identity and relatedness.
Conclusion: The model suggests studies that could be conducted to both prevent and treat this form of autism.
|Study Type :||Observational|
|Actual Enrollment :||1 participants|
|Official Title:||Participant(s) With Autism and High Pain Tolerance Treated With High Dose Naltrexone|
|Actual Study Start Date :||October 1, 2018|
|Actual Primary Completion Date :||May 24, 2021|
|Actual Study Completion Date :||May 24, 2021|
- Drug: 50 mg naltrexone
Medication combined with twice a week psychotherapy
- improvement of social responsiveness scale (SRS) and social communication questionnaire (SCQ) [ Time Frame: After two weeks at optimal naltrexone dose ]evaluation by patient at baseline and follow up of SRS and his father SCQ
- Cold Pressor Time [ Time Frame: After a week on optimized naltrexone dose with repeat two weeks later ]At baseline and after optimized naltrexone dosing
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05100563
|United States, New York|
|Upstate Medical University|
|Syracuse, New York, United States, 13210|