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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05100563
Enrollment
1
Registered
2021-10-29
Start date
2018-10-01
Completion date
2021-05-24
Last updated
2022-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Brief 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.

Interventions

DRUG50 mg naltrexone

Medication combined with twice a week psychotherapy

Sponsors

State University of New York - Upstate Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Diagnosis of autism -

Exclusion criteria

Lack of ability to give informed consent \-

Design outcomes

Primary

MeasureTime frameDescription
improvement of social responsiveness scale (SRS) and social communication questionnaire (SCQ)After two weeks at optimal naltrexone doseevaluation by patient at baseline and follow up of SRS and his father SCQ

Secondary

MeasureTime frameDescription
Cold Pressor TimeAfter a week on optimized naltrexone dose with repeat two weeks laterAt baseline and after optimized naltrexone dosing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026