This trial is active, not recruiting.

Condition tinnitus
Treatments acamprosate, placebo
Phase phase 1
Sponsor Oregon Health and Science University
Start date January 2008
End date December 2010
Trial size 300 participants
Trial identifier NCT00596531, 00003412, IRB00003412


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Subjects taking acamprosate
acamprosate Campral
Oral administration, 666 mg, tid, for 4 months
(Placebo Comparator)
Subjects taking placeboes
Oral administration of 2 pills, tid, for 4 months

Primary Outcomes

Tinnitus Handicap Index Tinnitus Functional Index Tinnitus loudness score on visual numerical scale
time frame: 15 months

Secondary Outcomes

Depression Inventory Psychoacoustic measures of tinnitus
time frame: 15 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Concurrent treatments: Amplification, sound generators or cochlear implants are permitted, provided they 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. - 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. - Tinnitus etiology: All forms of tinnitus etiology will be accepted into Phase I providing they meet the following tinnitus criterion. Duration: 1 year or longer. Stability: Constant. Severity: > 50th percentile of OHSU Tinnitus Patients based upon Tinnitus Functional Index scores. Rated loudness: >6 on a 0-10 visual numerical scale. Tinnitus location: Unrestricted. Exclusion Criteria: - Medical conditions: Active neurologic or otologic disease processes that may impact tinnitus perception. Auto-immune diseases. Pregnancy or planned pregnancy during the study. - Renal function: Subjects with documented renal disorders will be excluded if renal function has creatinine clearance is <50 mL/minute. - Digestive tract problems: Subjects with digestive tract disorders will be excluded. - Psychological status: Beck Depression Inventory score of greater than 15. - Tinnitus duration: Less than 1 year. Stability: pulsatile, intermittent, varying to a high degree in loudness or changing in location of perception.

Additional Information

Official title Clinical Trial of Acamprosate for Tinnitus
Principal investigator William H Martin, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.