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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05100563
Recruitment Status : Completed
First Posted : October 29, 2021
Last Update Posted : May 11, 2022
Sponsor:
Information provided by (Responsible Party):
State University of New York - Upstate Medical University

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

Condition or disease Intervention/treatment
Autism Spectrum Disorder Drug: 50 mg naltrexone

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.

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Participant(s) With Autism and High Pain Tolerance Treated With High Dose Naltrexone
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : May 24, 2021
Actual Study Completion Date : May 24, 2021

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adolescents and adults with autism spectrum disorder
Criteria

Inclusion Criteria: Diagnosis of autism -

Exclusion Criteria: Lack of ability to give informed consent

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05100563


Locations
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United States, New York
Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
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Responsible Party: State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT05100563    
Other Study ID Numbers: aUTISM01
First Posted: October 29, 2021    Key Record Dates
Last Update Posted: May 11, 2022
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents