Status:
COMPLETED
Fibromyalgia and Naltrexone: The FINAL Study
Lead Sponsor:
Odense University Hospital
Collaborating Sponsors:
University of Southern Denmark
University Hospital Bispebjerg and Frederiksberg
Conditions:
Fibromyalgia
Eligibility:
FEMALE
18-64 years
Phase:
PHASE2
Brief Summary
This study evaluates the effect of low dose naltrexone (LDN) on pain in women with fibromyalgia (FM). The study is designed as a parallel randomized (1:1) double blind, placebo-controlled superiority ...
Detailed Description
Low dose naltrexone (LDN) is used widely as off label treatment in patients with fibromyalgia, despite the lack of larger randomized controlled trials (RCT) supporting an effect. LDN has antagonistic...
Eligibility Criteria
Inclusion
- Women aged 18-64 years
- Understands and writes Danish
- Fulfills the American College of Rheumatology 1990 criteria for fibromyalgia
- A minimum score of 4 in self-reported average pain during the last 7 days on a 0-10 numeric rating scale at baseline
- All fertile women have to use safe anti conception (Spiral, birth control pills, contraceptive patch, contraceptive vaginal ring or gestagen injections) for 3 weeks before and 1 week after the trial. If the patients' normal lifestyle includes sexual abstinence, they do not have to use anti conception. Instead they can give an oral informed consent, that they will be sexually abstinent during the trial. A woman is considered non-fertile if she is sterilized, hysterectomized, bilateral oophorectomized or is postmenopausal. A woman is considered postmenopausal when vaginal bleeding has been absent for 1 year and is confirmed by measurement of follicle-stimulating hormone.
Exclusion
- Known allergy against naltrexonehydroclorid
- Pregnancy or breastfeeding. A negative pregnancy test has to be available for all fertile subjects at baseline
- Use of opioids or NSAIDs during the 4 weeks before inclusion in the trial
- Abuse of alcohol or other substances
- Inflammatory rheumatic diseases
- Demyelinating diseases
- Active cancer
- Liver dysfunction
- Kidney dysfunction
- Psychotic diseases
- History of suicide attempts
- Suicide ideation - evaluated using Patient Health Questionnaire-9 (Item 9 has to be answered "never")
Key Trial Info
Start Date :
January 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2022
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04270877
Start Date
January 6 2021
End Date
December 27 2022
Last Update
December 29 2022
Active Locations (1)
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1
Pain centre, Odense University Hospital
Odense, Denmark, 5000