NCT05100563

Completed

Participant(s) With Autism and High Pain Tolerance Treated W...

State University of New York - Upstate Medical University Source

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Other study identifiers

Sponsor study identifier

aUTISM01

Study Type

observational

Actual enrollment (reported)

1

Locations

1 country

Sites

1

Timeline

Study Start

October 1, 2018

Actual (reported)

Primary Completion

May 24, 2021

Actual (reported)

Study Completion

May 24, 2021

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 1 participants
Study completion date: May 24, 2021
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 1, 2018
Actual (reported)
First Submitted
October 22, 2020
Actual (reported)
Primary Completion
May 24, 2021
Actual (reported)
Study Completion
May 24, 2021
Actual (reported)
First Posted
October 29, 2021
Actual (reported)

Last Updated: May 11, 2022
Status Verified: November 2020
Last Update Submitted: May 10, 2022

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

Cold Pressor Time
After a week on optimized naltrexone dose with repeat two weeks later

Interventions

50 mg naltrexoneDrug

Medication combined with twice a week psychotherapy

Eligibility Criteria

Age12 Years - 80 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Adolescents and adults with autism spectrum disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

State University of New York - Upstate Medical University
Otherlead

Study Sites (1)

Upstate Medical University

Syracuse, New York, 13210, United States

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More Rings

Enrollment

1 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 29, 2021

Study Start

October 1, 2018

Actual (reported)

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NCT03771560

Folinic Acid in Autism

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NCT03195465

The Effect of High Antioxidant Cacao on Behaviors in Children With Autism Spectrum Disorder

Not ApplicableTerminated

NCT03538431

Improving Driving in Young People With Autism Spectrum Disorders

Phase 4Completed

Heterocyclic Compounds, Fused-Ring

Phenanthrenes

Polycyclic Aromatic Hydrocarbons

Polycyclic Compounds

Primary Completion

May 24, 2021

Actual (reported)

Study Completion

May 24, 2021

Actual (reported)

Last Updated

May 11, 2022

Record last verified: 2020-11

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05100563
Data provider: ClinicalTrials.gov
Source updated: 2022-05-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:42 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations