99
Participants
Start Date
January 6, 2021
Primary Completion Date
December 27, 2022
Study Completion Date
December 27, 2022
Naltrexone Pill
Treatment with LDN for 12 weeks, including af titration phase of 4 weeks. Initial dosage of 1.5 mg, dose is increased by 1.5 mg every 7th day to 6 mg at week 4. Dosing is increased based on safety and tolerability and delayed increments are allowed. The participants are maintained on the highest tolerable dose for the last 8 weeks of the treatment period.
Placebo oral tablet
Treatment with LDN-placebo for 12 weeks, including af titration phase of 4 weeks. Initial dosage of 1.5 mg, dose is increased by 1.5 mg every 7th day to 6 mg at week 4. Dosing is increased based on safety and tolerability and delayed increments are allowed. The participants are maintained on the highest tolerable dose for the last 8 weeks of the treatment period.
Pain centre, Odense University Hospital, Odense
University of Southern Denmark
OTHER
University Hospital Bispebjerg and Frederiksberg
OTHER
Odense University Hospital
OTHER