Clinical Trial of Acamprosate for Tinnitus

The first phase is an open-label screening study to identify subjects responding to acamprosate.

  1. Tinnitus Talk
    The objective of this project is to determine whether acamprosate is more effective at providing relief for tinnitus than a placebo.

    Acamprosate has been suggested to be effective in reducing tinnitus annoyance in a preliminary study. Study evidence indicates that tinnitus is related to increased excitatory spontaneous brain activities. Acamprosate may help restore the excitatory/inhibitory balance in the brain and thus reduce tinnitus.

    The current study includes three phases. The first phase is an open-label screening study used to identify tinnitus subjects responding to acamprosate. These responding subjects will enter the second phase, which is a double blind, placebo-controlled study aimed at confirming the subjects' responses to acamprosate. In the third phase, clinical parameters of both responders and non-responders will be compared using a multi-linear regression model to determine characteristics that define the sub-group of tinnitus patients that are likely to benefit from acamprosate treatment. Participation in the study requires that individuals come to Portland, Oregon at least 6 times over 16 months for evaluation and data collection.

    Estimated Enrollment: 300
    Study Start Date: January 2008
    Estimated Study Completion Date: December 2010
    Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)