Butrans for Treatment of Restless Legs Syndrome

Inclusion Criteria: * Subject has a diagnosis of RLS, defined by International Restless Legs Study Group (IRLS) essential criteria: * An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. * The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying down or sitting. * The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues. * The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. * Subject has moderate to severe RLS symptoms,defined as an International Restless Legs Scale (IRLS) score greater than or equal to15 at the baseline visit (visit 2). * Subject has RLS symptoms that, in the opinion of the investigator, require round-the-clock treatment. * Subject speaks and reads English. * Subject is able to provide informed consent. * Subject is age ≥25 and ≤75. * Subject has BMI ≥18 and ≤35 * Subject is naïve to opioid treatment, defined as subjects not having received ≥5 mg oxycodone in the past 14 days and no history of daily use of ≥5 mg oxycodone equivalents in the past 3 months. * If subject is currently being treated for RLS, s/he must have an inadequate response to or be intolerant of current, non-opioid regimen. * If subject is not currently being treated for RLS, s/he must have a contraindication to or a history of intolerance to non-opioid treatment options for RLS, concerns about side effects of such options, or a preference for non-oral medication. * If subject is currently being treated with a medication for RLS, a washout period of at least 3 days will be required (or 5 half-lives for longer-acting agents). * Subject's history and/or clinical records document no change in medications active in the central nervous system (antidepressants, analgesics, antipsychotics, antiepileptics, hypnotics, etc.) for at least 30 days prior to visit 1. * Subject is able to understand study procedures and agrees to remain on stable medications during the period of the study. * Women of childbearing potential must agree to use a medically accepted method of birth control. Acceptable forms of birth control include: * Condom + spermicide * Diaphragm + spermicide * Oral contraceptive pills, hormone implants (like Norplant), or injections(like Depo-Provera) * Intrauterine Device Exclusion Criteria: * Lifetime history of DSM-IVopiod, alcohol, or other substance abuse. * History of opioid treatment for RLS with inadequate response * Positive urine toxicology screen at visit 1. * Another chronic pain syndrome that would, in the opinion of the investigator, interfere with evaluation of RLS symptoms or the response to the study medication. * Plan to undergo a procedure that may require short or long-term opiates for pain control during the course of the trial. * History of severe mental illness. * Women who are pregnant, lactating, or planning to become pregnant. * Shift work or other commitments that do not allow for regular sleep at night. * Known hypersensitivity or intolerance to opioids. * History of Long QT Syndrome or an immediate family member with this condition, or known prolongation of QTc interval. * QTc interval prolongation \>500 ms on screening EKG at Visit 1. * History of malignant melanoma. * Current use of monoamine oxidase inhibitors. * Prior or current clinically significant impulse control disorder, as determined by clinical interview and the Modified Minnesota Impulse Disorders Interview at Visit 1.8 * Untreated severe sleep apnea, defined as AHI \>30. * Iron deficiency, defined as ferritin\<15 at Visit 1. * Any dermatologic condition resulting in widespread compromise of skin integrity, defined as \>50% of the surface area within the 8 sites described for BTDS application. * Current use of class IA or class III anti-arrhythmic medication. * Significant risk for suicide by clinical interview. * Known hypersensitivity to buprenorphine or any excipient of BTDS. * Current unstable medical illness. * Any medical or psychiatric condition that, in the opinion of the investigator, would interfere with participation in the study.