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

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

Detailed Description
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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.

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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Drug: 50 mg naltrexone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of autism - Exclusion Criteria: Lack of ability to give informed consent -

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 50 mg naltrexone|Medication combined with twice a week psychotherapy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | After two weeks at optimal naltrexone dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cold Pressor Time | At baseline and after optimized naltrexone dosing | After a week on optimized naltrexone dose with repeat two weeks later |