Oregon Health & Science University

Oregon Hearing Research Center

OHSU Tinnitus Clinic

Tinnitus Clinic Current Research Studies
 

CLINICAL TRIAL OF ACAMPROSATE FOR TINNITUS (OHSU IRB 3412)

Purpose: to determine whether Acamprosate is more effective in providing relief for tinnitus than a placebo.

Background: Acamprosate (Campral) has been suggested to be effective in reducing tinnitus annoyance in a preliminary study. Research evidence indicates that tinnitus may be related to increased excitatory brain activities. Campral may help restore the excitatory/inhibitory balance in the brain and thus reduce tinnitus.

Details of the study:

  • Phase I: will be a screening study used to identify individuals with tinnitus who respond to Campral. It will last six weeks, during which participants will take two Campral pills three times a day. Participants will be evaluated at the OHSU Tinnitus Clinic at the beginning and end of this phase to determine if the Campral has been helpful. If the Campral is very helpful to a participant, he or she may be eligible to participate in a second phase of the study.

  • Phase II: begins at least four weeks after conclusion of the first phase. Phase II is designed to confirm Acamprosate’s effects on a subject through a double-blinded approach, this means that each participant will be given either the study drug or a placebo for the first part of Phase II and then they will switch to the opposite for the second part. The order of which of the two (Campral and placebo) will be taken first is randomized and neither the participants nor the researchers in direct contact with the participants will know what the participants are taking at any given time during the entire second phase. This design will prevent placebo effects from affecting the study results. However, if necessary, the true identity of the drug being taken can be revealed through the research staff in charge of the information. Participants will return for repeated tinnitus evaluations at the beginning and ending of each six month test period in this phase of the study.

    Participants will be asked to visit the OHSU Tinnitus Clinic a few times for evaluation and testing. Each visit will be 1-2 hours long and involve audiometric and tinnitus testing in a sound-booth. Participants will take Acamprosate or placebo for 6 months each with at least a one-month wash-out period (no study medications) in-between. Phase II of the study will take 13 months of your participation. You will be asked to complete and send back questionnaires several times during this time, in addition to the clinic testing and evaluation.

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  • Phase III: we will review test results and answers to questionnaires to determine characteristics that define the sub-group of tinnitus patients that are likely to benefit from Campral treatment. Study participants will not directly participate in this Phase.

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  • Eligibility: To ensure accurate study results, individuals will be eligible only if they meet very specific criteria in terms of their tinnitus and general health. Those who qualify and are interested will give written consent to participate in the study. Information about the study will be provided and participants will be given a chance to ask questions before signing the consent.

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  • Time Commitment: If participating in both Phases I and II, will be about 15 months, with a total of six visits to the OHSU Tinnitus Clinic. Each visit will last between 40 minutes and four hours.

  • Side Effects: While having an excellent safety profile, Campral may cause mild side effects, mainly stomach upset and/or diarrhea. Severe side effects are rare but possible.
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Linda C. Howarth, Project Coordinator
OHSU Tinnitus Clinic
3181 SW Sam Jackson Park Road (NRC04)
Portland, OR 97239
Telephone: (503) 494-0670
Fax: (503) 494-5656
howarthl@ohsu.edu

Research Screening Form

 

"Eligibility Information

Needed: Subjects for Clinical Trial for Tinnitus Treatment

The OHSU Tinnitus Clinic is conducting a clinical trial of a medication to determine its ability to relieve long-standing, stable and bothersome tinnitus. The medication is acamprosate.

The following criteria for inclusion are necessary:
Age/Gender: 18-75 years of age.
Duration of tinnitus: At least one year.
Other concurrent treatments: Individuals using hearing aids, sound generators or cochlear implants, are permitted provided the devices have been in use for at least one year. A four-week washout from any other tinnitus treatment or management program is required prior to entering this study.
Other medications: No restrictions provided the dosages have been in place for at least 6 months and they are not contraindicated as concurrent medications with acamprosate.
Medical conditions: No active neurologic or otologic disease processes that may impact tinnitus perception. No auto-immune diseases. No pregnancy or planned pregnancy during the study.
Renal function: Subjects with active kidney disease may not participate in the study.
Digestive tract problems: Subjects with chronic digestive tract disorders will be excluded from the study.
Hearing function: All levels of hearing function can be included recognizing that profound, bilateral losses will not be able to perform psychophysical tinnitus and hearing tests but will be able to rate subjective loudness, annoyance and impact on life.

If you meet these criteria and are interested in participating in this study please call 503 494-2955 and leave your name and phone number and/or email address and we will get back to you .

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