Foundation Funds Study on Use of Opioids for RLS

An excerpt from the Summer 2017 edition of NightWalkers, the Foundation's quarterly magazine

The RLS Foundation has awarded a $144,000 grant to John Winkelman, MD, PhD, of Harvard Medical School, for a pilot study on the use of opioids to treat RLS. The two-year project is part of broader research to establish the long-term safety and effectiveness of opioids for treating the disease.

“This opioid registry is long overdue. It is important to establish the long-term safety and effectiveness of opioid treatment in RLS in order to distinguish it from the current literature on opioids in chronic pain,” says Christopher J. Earley, MB, BCh, PhD, FRCPI, who is chair of the RLS Foundation Scientific and Medical Advisory Board.

In the study, Dr. Winkelman and his team will recruit 200 patients from across the US who are taking opioids for RLS. The team will collect data on opiate medication and dose, severity of RLS symptoms, opiate side effects, sleep quality and augmentation. The first two years of data collection, supported by the RLS Foundation grant, will establish the parameters for ongoing, long-term research and enable the team to apply for further funding for this work.

Opioid use to treat RLS has increased over the past decade as other drugs have fallen short of meeting the needs of patients. Notably, dopamine drugs, which initially may relieve RLS symptoms, are now known to make symptoms worse over time for many people – a side effect called augmentation.

For many RLS patients, opioids are a beneficial alternative. Existing studies show that taking them at low doses can bring dramatic relief of RLS symptoms with minimal side effects.

Information is lacking about the long-term effects of opioids, however. A primary aim of the new study is to “fill that vacuum with reliable data,” says Dr. Winkelman. “In the absence of information, we have hypotheses, hunches, speculation, prejudice… And in medicine, we want to identify reliable information and data to benefit patients. The more information we have about the use of these medications in RLS, the better we’ll be able to guide patients’ decisions about the risks and benefits.”

The research also aims to address concerns in the US about using opioids to treat long-term conditions like RLS. In the midst of the nationwide opioid crisis, providers who prescribe them are under increased scrutiny, and many states have stepped up regulation.

“The concern is that some states may be so aggressive in their control of opiates that they restrict access to opiates for people who genuinely need them and are using them appropriately,” says Dr. Winkelman.

By disseminating and publishing their study results, the researchers hope to provide information for policy makers to form reasoned, scientific decisions about the use of opioid medications for RLS.

For Dr. Winkelman, this current research continues his long involvement in the field of RLS, which he says began early in his sleep medicine career when he started seeing patients with the disorder.

“There was so little known about this, and so many people who had been wandering in the wilderness of medicine, bouncing from doctor to doctor without any recognition from the medical community. The level of awareness has really grown in 25 years, and treatment options have grown as well.”

“It’s been extremely gratifying to have participated in this area of medicine over the last 25 years – see it change and be part of that change – and be a resource for patients and say to them, ‘I don’t know everything about this, but I feel secure in giving you the best information that exists.’”

John W. Winkelman, MD, PhD, is an associate professor of psychiatry at Harvard Medical School and director of the RLS Quality Care Center at Massachusetts General Hospital. He has served on the RLS Foundation Medical Advisory Board (now the Scientific and Medical Advisory Board) since 2000, and on the Executive Committee of the International Restless Legs Syndrome Study Group. He is also chair of the Treatment Guideline Committee for the treatment of RLS at the American Academy of Neurology.

Dr. Winkelman’s research interests include sleep-related movement disorders, insomnia and parasomnias. He is a leading expert on RLS, has published several textbooks, and has authored over 100 articles in sleep medicine. Notably for RLS, he published seminal work on cardiovascular disease and on end-stage renal disease, and he was lead author on the American pivotal trial of pramipexole to treat RLS.

How to participate in the study

Recruitment for the study “Multicenter Longitudinal Pilot Observational Study of Efficacy and Tolerability of Long-Term Treatment of Restless Legs Syndrome Using Opioids” is expected to begin in late 2017. Participants will have an initial 30- to 60-minute phone interview with a clinical research team at Massachusetts General Hospital, after which they will provide information through surveys on a secure website hosted at Massachusetts General.

Information will be de-identified to protect privacy. Participants will receive an annual summary of their data, as well as a yearly newsletter summarizing all study data. If you are interested in participating in the study, watch for more information on the RLS Foundation website at www.rls.org.