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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05100563
• Other study ID #: aUTISM01
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: May 24, 2021

Study information

• Verified date: November 2020
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 24, 2021
• Est. primary completion date: May 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

Inclusion Criteria: Diagnosis of autism -

Exclusion Criteria: Lack of ability to give informed consent

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Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Drug:
• 50 mg naltrexone
Medication combined with twice a week psychotherapy

Locations

Country	Name	City	State
United States	Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cold Pressor Time	At baseline and after optimized naltrexone dosing	After a week on optimized naltrexone dose with repeat two weeks later