NCT05100563

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: State University of New York - Upstate Medical University · Academic / Other
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	50 mg naltrexone	Medication combined with twice a week psychotherapy

Timeline

• Start date: 2018-10-01
• Primary completion: 2021-05-24
• Completion: 2021-05-24
• First posted: 2021-10-29
• Last updated: 2022-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study