A study on the effects of the FDA approved drug Modafinil upon attention problems associated
with tinnitus. This is considered to be a safe drug with few side effects. Each subject will
be asked to participate in 3 sessions each lasting approximately 1 hour in which cognitive
testing and recordings will be taken. The study involves each subject taking a 2- week
supply of Modafinil and a 2- week supply of placebo. We hypothesize inattention related to
thalamocortical dysrhythmia found in tinnitus can be reduced by Modafinil thus improving
Modafinil, a drug primarily used in the treatment for narcolepsy, is also being using in
treating attention problems found in Attention Deficit Hyperactive Disorder (ADHD). This
study will investigate the efficacy of Modafinil upon attention deficits found in tinnitus
patients by assessing pre-attentional and attentional processes (e.g., the amplitude of
auditory evoked responses and simple reaction time).
- The diagnosis of tinnitus should be established by subject through exam and history
performed by study physician in Ear, Nose and Throat (ENT) clinic.
- Subjects will be age 20 or older.
- Subjects should have tinnitus symptoms severe enough to seek medical attention.
- Subjects will have been seen in the Hearing and Balance Center at University of
Arkansas for Medical Sciences (UAMS).
- Subjects will have had an audiogram.
- Signed informed consent.
- Women of childbearing potential must have a negative pregnancy test at screening and
before being prescribed the study drug.
- Peripheral neuropathy.
- Hematologic (minimal values) at screening Absolute neutrophil count > 1,500 mm^3
Hemoglobin > 8.0 g/dl Platelet count > 100,000 mm^3
- Subjects who have locally advanced breast cancer with skin ulceration will be
excluded from this study due to the risk of worsening ulcers and healing difficulties
- Stage IV breast cancer
- Inflammatory breast cancer
General Medical Concerns
- Subjects with Echo Cardiogram performance status 2, 3, and 4 are not eligible for
- Allergy to any component of the treatment regimen
- Women who are breast feeding
- Pregnancy or refusal to use effective contraception while participating in this study
- Inability to comply with study and/or follow-up procedures
- Subjects with secondary malignancy other than superficial skin cancer (squamous cell
carcinoma and basal cell carcinoma of the skin) should be excluded
- Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in an experimental drug study
- Blood pressure of > 150/100 mmHg. Essential hypertension well controlled with anti
hypertensive is not an exclusion criterion
- Unstable angina
- New York Heart Association (NYHA) Grade II or greater congestive heart failure (see
- History of myocardial infarction within 6 months
- History of stroke within 6 months
- Clinically significant peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Presence of central nervous system or brain metastases
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0, anticipation of need for major surgical procedure during the course
of the study
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7
days prior to Day 0
- Pregnant (positive pregnancy test) or lactating
- Urine protein: creatinine ratio >1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture