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Clinical Trial of Acamprosate for Tinnitus

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ClinicalTrials.gov Identifier: NCT00596531
Recruitment Status : Completed
First Posted : January 17, 2008
Last Update Posted : November 8, 2016
Information provided by (Responsible Party):
William Hal Martin, Oregon Health and Science University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Tinnitus Drug: Acamprosate Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial of Acamprosate for Tinnitus
Study Start Date : January 2008
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Active Comparator: A

Subjects will take acamprosate (Campral) at a dose of 666 mg. three times daily (morning, lunch time, bed time) for 28 days. Only responders will be included in the subsequent double-blind cross over arms after a minimum washout period of 4 weeks.

Subjects will randomly be assigned to Group 1 (A/B) or Group 2 (B/A) after completion of Phase I and its subsequent washout period (Figure 1, periods 1 and 2). Group 1 will receive acamprosate (Campral) at a dose of 666 mg. three times daily for 24 weeks followed by a 4-week washout period

Drug: Acamprosate
Oral administration, 666 mg, tid, for 4 months
Other Name: Campral

Placebo Comparator: B
Group 2 will be assigned to the placebo group and take matched placebos for next 24 weeks followed by a 4-week washout period. After the washout period each group will be assigned to the other intervention (acamprosate or placebo) and complete another trial for 24 weeks.
Drug: Placebo
Oral administration of 2 pills, tid, for 4 months

Primary Outcome Measures :
  1. Tinnitus Handicap Index Tinnitus Functional Index Tinnitus loudness score on visual numerical scale [ Time Frame: 15 months ]

Secondary Outcome Measures :
  1. Depression Inventory Psychoacoustic measures of tinnitus [ Time Frame: 15 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596531

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United States, Oregon
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
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Principal Investigator: William H Martin, Ph.D. Oregon Health and Science University
Principal Investigator: Yongbing Shi, M.D., Ph.D. Oregon Health and Science University
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Responsible Party: William Hal Martin, Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00596531    
Other Study ID Numbers: 00003412
First Posted: January 17, 2008    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Keywords provided by William Hal Martin, Oregon Health and Science University:
clinical trial
Additional relevant MeSH terms:
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Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Alcohol Deterrents