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OpenTrials
Completed

NCT Number: NCT05100563

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

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

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

12 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Upstate Medical University

Syracuse, New York, 13210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of autism -

Exclusion criteria

Lack of ability to give informed consent

-

Treatment and study plan

50 mg naltrexone

Drug

Medication combined with twice a week psychotherapy

Primary outcomes

  1. 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

Secondary outcomes

  1. Cold Pressor Time

    Time frame: After a week on optimized naltrexone dose with repeat two weeks later

    At baseline and after optimized naltrexone dosing

Sponsors and collaborators

Lead sponsor

State University of New York - Upstate Medical University

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2021
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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