Clinical Trial of Acamprosate for Tinnitus
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Clinical Trial of Acamprosate for Tinnitus|
- Tinnitus Handicap Index Tinnitus Functional Index Tinnitus loudness score on visual numerical scale [ Time Frame: 15 months ]
- Depression Inventory Psychoacoustic measures of tinnitus [ Time Frame: 15 months ]
|Study Start Date:||January 2008|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
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
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.
Oral administration of 2 pills, tid, for 4 months
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00596531
|United States, Oregon|
|Portland, Oregon, United States, 97239|
|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|