Participant(s) With Autism and High Pain Tolerance Treated With High Dose Naltrexone
1 other identifier
observational
1
1 country
1
Brief Summary
High dose naltrexone with response gauged by pain tolerance as measured by the cold pressor test may help treat autism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2021
CompletedFirst Posted
Study publicly available on registry
October 29, 2021
CompletedMay 11, 2022
November 1, 2020
2.6 years
October 22, 2020
May 10, 2022
Conditions
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
Medication combined with twice a week psychotherapy
Eligibility Criteria
Adolescents and adults with autism spectrum disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Upstate Medical University
Syracuse, New York, 13210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
Primary Completion
May 24, 2021
Study Completion
May 24, 2021
Last Updated
May 11, 2022
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share