An observational study in Autism Spectrum Disorder, sponsored by State University of New York - Upstate Medical University. Completed at 1 site in United States. Open to participants aged 12 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-11.
Sponsored by State University of New York - Upstate Medical University · Observational
High dose naltrexone with response gauged by pain tolerance as measured by the cold pressor test may help treat autism.
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 1 is below the median of 102 across 267 observational studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →State University of New York - Upstate Medical University is the lead sponsor of 154 studies on the registry; 17 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 4 (36%) have results posted.
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Adolescents and adults with autism spectrum disorder
Inclusion Criteria: Diagnosis of autism -
Exclusion Criteria: Lack of ability to give informed consent
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Medication combined with twice a week psychotherapy
improvement of social responsiveness scale (SRS) and social communication questionnaire (SCQ)
evaluation by patient at baseline and follow up of SRS and his father SCQ
Time frame: After two weeks at optimal naltrexone dose
Cold Pressor Time
At baseline and after optimized naltrexone dosing
Time frame: After a week on optimized naltrexone dose with repeat two weeks later
Plan to share: No
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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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State University of New York - Upstate Medical University