ow Dose Naltrexone in Fibromyalgia - A randomised controlled cross-over trial

Phase 4

• Conditions: fibromyalgia; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12623000172606
• Lead Sponsor: Metro South Hospital and Health service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-20
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

a)at least 18 years old;
b)diagnosis of FMS according to ACR 2011 criteria by a pain specialist or rheumatologist
c)oral morphine equivalent daily dose (OMEDD) less than 60mg;
d)provision of written informed consent;
e)able to complete questionnaires.

Exclusion Criteria

f)current treatment with naltrexone;
g)severe medical or psychiatric illness likely to limit life or participation in trial;
h)pregnant or planning pregnancy during study period;
i)known allergy to naltrexone or naloxone;
j)currently participating in other clinical trials.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evel of pain severity as measured by Fibromyalgia Impact Questionnaire, Revised (FIQR) (Symptoms Domain, Question 1): average pain intensity during the last 7 days on an 11- point rating scale (ranging from 0 = no pain” to 10 = unbearable pain”).[Outcomes will be measured at Visit 1 Commencement, Visit 2 (halfway: 6 weeks after commencement) and Visit 3 (Primary timepoints: 12 weeks after commencement) . ]