The National Rls Opioid Registry: Baseline Data On The First 300 Participants

Restless Legs Syndrome (RLS) is a sensory-motor neurological disorder which is associated with sleep disturbance and emotional distress. Low-dose opioid medications are used for patients who are refractory to, or do not tolerate, first-line RLS treatments. This observational longitudinal study will collect outcomes on RLS treatment efficacy and opioid dosages in a national sample of patients. We now report cross-sectional data on the first 300 patients enrolled in this study. Patients currently taking an opioid for diagnosed RLS who had a previous therapeutic response to dopaminergic agonists were recruited. A baseline phone interview and online (REDCap) survey collected information on initial and current opioid dosages, side effects, past/current RLS treatments, RLS severity, psychiatric history, and opioid abuse risk factors (Opioid Risk Tool). All data is stored in a secure online database. Participants (n=300) are primarily white (98%), elderly (mean age=64.9), educated, and retired. Half of all subjects are on opioid monotherapy for RLS, and 21% of subjects are additionally taking gabapentin or pregabalin. Nearly 50% of subjects are taking methadone (mean dose=10.3 mg), and one-third are taking oxycodone formulations (mean dose=25.7 mg). Median IRLS score=13.0; one-fifth of subjects have been RLS symptom-free (IRLS=0) in the past week, and 15% in the past month. More than half of subjects have a history of psychiatric illness, predominantly depression and anxiety disorders. Prior to opioid initiation, 38% of subjects had passive, and 20% active, suicidal ideation, with significant reductions in both (p<0.0001) after opioid initiation. Over three-quarters of this sample is low risk for opioid abuse. Over a median of 3-5 years, 53% of subjects have not increased their opioid dose, and median dose increase in others is 15.5 mg morphine equivalents. Low doses of opioids are associated with moderate control of RLS symptoms in patients refractory to other treatments, and who commonly have a history of psychiatric comorbidity. Longitudinal data will examine ongoing RLS treatment efficacy, tolerability, and opioid dosages. RLS Foundation