Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-02-25 @ 8:27 PM
Study NCT ID:
NCT02965768
Status:
WITHDRAWN
Last Update Posted:
2022-09-02
First Post:
2016-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Effects of Low-dose Naltrexone in ME/CFS
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
The Immune Effects of Low-dose Naltrexone in People With Myalgic Encephalopathy/Chronic Fatigue Syndrome (ME/CFS)
Status:
WITHDRAWN
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was temporarily suspended to focus on other projects, but was never resumed. No participants were determined eligible and none started the protocol.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of this study is to test if naltrexone, when taken in low doses, has an anti-inflammatory effect that may be associated with positive clinical outcomes in people with chronic fatigue syndrome (CFS). In part, the present study, is a continuation of prior work in which we showed that chronic fatigue symptoms are associated with immune activity, and that low-dose naltrexone might exert anti-inflammatory effects in fibromyalgia, which is thought to share some pathophysiological and clinical characteristics with CFS.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: