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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
- 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 ]
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
|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|