Use of Modafinil in the Treatment of Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Intervention: Modafinil; Placebo
Intervention description: 200 mg/day, morning dose; Sugar pill once per day in the morning.
Intervention MeSH terms: Modafinil
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Single (Participant)
Enrollment: 7.0
Sex: All
Minimum age: 20 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: P50, Psychomotor Vigilance Test (PVT), Arousal, Reaction Time

Summary:

      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
      vigilance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

        Disease-Specific Concerns

          -  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 this
             study

          -  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

        Bevacizumab-Specific Concerns

          -  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
             Appendix D)

          -  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