Transdermal Lidocaine as a Treatment for Tinnitus

Potential research participants will be recruited from the UC Davis Otolaryngology clinic. For this investigation, the investigators will be using the Tinnitus Functional Index, a standardized and validated survey for the impact of tinnitus on an individual's life. The study design will be an unblinded, quasi-experimental protocol to ascertain if transdermal lidocaine can reduce subjective tinnitus. This initial investigation will be studying the efficacy of 5% transdermal lidocaine patches in the treatment of tinnitus. Transdermal lidocaine is currently approved by the FDA for the treatment of post-herpetic neuralgia, but it is used off label for a wide assortment of conditions. The investigators will be following the guidelines used for the general use of transdermal lidocaine and will remain within the dosing approved by the FDA. The investigators intend to sequentially recruit 44 participants for this study, in the order that they present to the UC Davis Otolaryngology clinic.

SUBJECTS Eligible subjects are greater than 18 years of age and have had at least a history of chronic subjective tinnitus. Prior to enrollment, all potential subjects will be screened to see if they meet the inclusion and exclusion criteria as listed in Section 6. Once inclusion and exclusion criteria have been evaluated, appropriate participants will undergo the informed consent process. Following informed consent, all selected participants will undergo a full history and physical exam. We will not be performing a pre-enrollment EKG, as it is not required for the general use of transdermal lidocaine. Each subject will have had an audiogram performed as standard of care for evaluation and management of chronic tinnitus.

MATERIALS AND APPLICATION This investigation will utilize the UC Davis Otolaryngology clinic and its resource within for this investigation. TFI surveys will be provided for the participants. The drug used in this investigation will be 5% lidocaine patches (Endo Pharmaceuticals and Actavis Pharmaceuticals). Study drug will be prescribed by a physician in the Department of the Otolaryngology at UC Davis, to be filled at the pharmacy of the participant's choosing.

The transdermal lidocaine patches will be administered to the participant's torso, either the upper back or chest, at his or her preference. If an individual is so slight of build that he or she can not apply three patches to either his upper chest or upper back, then other locations will be considered, including low back, buttocks, and thighs. Patches will be applied first thing in the morning to these areas daily, and kept on for twelve hours. Following patch removal at night, the patient will undergo a twelve hour drug recess off of the transdermal lidocaine.

All relevant patient information including symptoms checklists, results of TFI, and other important patient care information will be recorded in the UC Davis Electronic Medical Record (EMR) for each encounter under the appropriate encounter subheading. These recording will be done in accordance with UC Davis Policies and Procedures manual Chapter 320, Section 10 Records and Archives: Records Management Program, as well as UC Davis Health Center's Code of Conduct, specifically referring to Standards 6, Creation and Retention of an Accurate Patient and Institutional Record, and 14, Clinical Research. The patient data will also be transposed into a REDCap database for patient tracking, evaluation, and analysis.