Still to open Australia: Double Blind 12 week Clinical Trial to investigate the effects of low dose naltrexone (LDN) in individuals with ME/CFS

Dolphin

Senior Member (Voting Rights)
NCNED Facebook page:

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NCNED is launching its first Double Blind 12 week Clinical Trial to investigate the effects of low dose naltrexone (LDN) in individuals with ME/CFS commencing in late March 2026.

We are currently seeking volunteers diagnosed by the CCC/ICC located in .

:
-Aged 18–65 years
-BMI between 18.5 and 29.9
-Not currently pregnant or breastfeeding
-Not taking routine medications that may interfere with naltrexone, such as opioids

Participants will receive LDN at doses of 3–6 mg/day for 12 weeks. The trial will evaluate:
-Ion channel function
-Brain MRI imaging (participants must be able to travel to Brisbane for MRI appointments)
-Quality of life and symptom assessments, including cognitive function, sleep, fatigue and body pain

The study aims to assess the effect of LDN on key biological markers and patient-reported symptoms, helping advance understanding of potential treatments for ME/CFS.

:
To register your interest or request further information, please email: ncned@griffith.edu.au

: At the end of 2026 NCNED will commence this Double Blind Clinical Trial in Victoria that will continue into 2027.

Best wishes,
Sonya and the NCNED team

NCNED would like to express our gratitude and appreciation to all the volunteers, Support Groups and the following Organizations:
• The Stafford Fox Medical Research Foundation
• National Health and Medical Research Council
• MERUK
• Dr John Hamwood
• The McCusker Charitable Foundation
• Mr Adrian Flack
• Talei Stewart
• The Alison Hunter Memorial Foundation
• The Buxton Foundation
• The Henty Community
• The Blake Beckett Foundation
• Change for ME Charity
• QLD ME/CFS/FM Support Association
• WA ME/CFS and Lyme Association
• Fibromyalgia ME/CFS Gold Coast Support Group Inc
• Tweed ME/CFS/FM Lyme Support Group
• ME/CFS South Australia Inc
• ME/CFS & FM Association NSW Inc
• ME/CFS Australia Ltd
• National Advocacy Advisory Council for ME/CFS

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This is ambiguous to say the least. The Facebook post says nothing about long covid, but the poster says participants must be diagnosed with "ME/CFS to CCC/ICC and long covid."
Agree.

I think they've already done a 12-week double blind trial for LC: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=386522

In this article from 2024 they said:
“We will be undertaking two clinical trials testing the efficacy of low dose naltrexone where the first will be in Long COVID patients while the second trial will, for the first time, be in ME/CFS patients,” Professor Marshall-Gradisnik said.
which would indicate the new trial would be for ME/CFS. Because they talk about similarities between LC and ME/CFS, I guess they mean ME/CFS not triggered by COVID.
 
I have a lot of questions:

Why only 3 months?
How long is followup before and after?
Will there be a placebo group?
Why no objective measurements of health like step count?
Has the ‘biological markers’ been established as relevant?
 
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