NCT00591019

Use of Modafinil in the Treatment of Tinnitus

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 20 Years – 99 Years
• Healthy volunteers: Accepted

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.

Detailed description

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).

Conditions

• Tinnitus

Interventions

Type	Name	Description
DRUG	Modafinil	200 mg/day, morning dose
OTHER	Placebo	Sugar pill once per day in the morning.

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-03-01
• Completion: 2008-06-01
• First posted: 2008-01-11
• Last updated: 2015-10-08
• Results posted: 2011-05-09

Locations

1 site across 1 country: United States