This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Clinical experience has indicated that sedating anti-histamines and diphenhydramine in particular exacerbated RLS. These investigators have previously evaluated the effect of diphenhydramine on the SIT test (a provocative test for RLS symptoms) in well controlled RLS patients. The SIT test showed diphenhydramine produced dramatic and marked worsening of RLS, much greater than lorazepam (another sedating medication) or placebo. It is unclear whether the adverse effect of diphenhydramine on RLS was due to direct effect on the disease or through interaction with dopaminergic medications. In addition to dopaminergic medications, RLS is also treated with opioids. These investigators seek to evaluate the diphenhydramine response for patients on opioids but not dopaminergic treatment for their RLS. These studies will lead to larger and more comprehensive clinical trials to evaluate the anti-histamine response for both treated and untreated patients as well as determine the relative affects of opioids and dopamine agonists on the histamine reaction. Thus, the primary hypothesis being addressed is that the anti-histamine effects in RLS occur because of underlying disease state and are not secondary to alteration of dopaminergic medications. Therefore, these investigators expect that patients treated with opioids for RLS treatment will demonstrate a similar response to diphenhydramine as the patients on dopaminergic treatment.
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