None listed
Conditions
Brief summary
Preliminary evidence shows that low-dose naltrexone (LDN) has a clinically beneficial impact on fibromyalgia pain, function and quality of life. However, only a few small clinical trials with high risk of bias have investigated the effect of LDN on fibromyalgia symptoms. The primary aim of this double-blind, randomised, controlled trial is to evaluate the efficacy of LDN in reducing pain in patients with fibromyalgia over a 12-week period.
Interventions
Capsule for oral intake, containing active ingredient (naltrexone) 1.5mg daily for one week, 3mg daily next week, 4.5mg daily for subsequent 6 weeks (8 weeks total). May be taken at any regular time during the day. There is an additional control period (creating a crossover design) of four weeks of placebo once daily, which is randomised to the beginning or end of the treatment period, resulting in 12 weeks of capsule taking for the participants. There is no wash-out period between active and pl
Capsule for oral intake, containing active ingredient (naltrexone) 1.5mg daily for one week, 3mg daily next week, 4.5mg daily for subsequent 6 weeks (8 weeks total). May be taken at any regular time during the day. There is an additional control period (creating a crossover design) of four weeks of placebo once daily, which is randomised to the beginning or end of the treatment period, resulting in 12 weeks of capsule taking for the participants. There is no wash-out period between active and placebo capsules. Study participants will be asked to return unused medicine at the end of the trial, and research team will have regular phone check-in (4-weekly) with them about their pain, during which investigators will verbally check on their compliance and unwanted effects.
Sponsors
Metro South Hospital and Health service
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed