Clinical Trial of Acamprosate for Tinnitus - Full Text View

Sponsored by:	Oregon Health and Science University
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00596531

Purpose

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.

Condition	Intervention	Phase
Tinnitus	Drug: Acamprosate Drug: Placebo	Phase I

MedlinePlus related topics: Tinnitus Toe Injuries and Disorders

Drug Information available for: Acamprosate Acamprosate calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Clinical Trial of Acamprosate for Tinnitus

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

Tinnitus Handicap Index Tinnitus loudness score on visual analogue scale Tinnitus annoyance score on visual analogue scale [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	186
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Subjects taking acamprosate	Drug: Acamprosate Oral administration, 666 mg, tid, for 6 months
B: Placebo Comparator Subjects taking placeboes	Drug: Placebo Oral administration of 2 pills, tid, for 6 months

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 Severity Index (TSI) scores. Rated loudness: > 7 cm from the left on a visual analog scale (VAS) 10 cm in length. Rated annoyance: > 7 cm from the left on a visual analog scale (VAS) 10 cm in length. 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. Severity: < 50th percentile of OHSU Tinnitus Patients based upon Tinnitus Severity Index (TSI) scores. Rated loudness: < 7 cm from the left on a visual analog scale (VAS) 10 cm in length. Rated annoyance: < 7 cm from the left on a visual analog scale (VAS) 10 cm in length.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596531

Contacts

Contact: William H Martin, Ph.D.

(503) 494-7954

martinw@ohsu.edu

Locations

United States, Oregon
OHSU	Recruiting
Portland, Oregon, United States, 97239
Contact: William H Martin, Ph.D. 503-494-7954 martinw@ohsu.edu
Principal Investigator: William H Martin, Ph.D.

Sponsors and Collaborators

Oregon Health and Science University

Investigators

Principal Investigator:

William H Martin, Ph.D.

Oregon Health and Science University

More Information

Responsible Party:	OHSU Tinnitus Clinic ( Martin, William Hal/Director )
Study ID Numbers:	00003412, 00003412
Study First Received:	January 8, 2008
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00596531
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

Tinnitus
acamprosate
clinical trial

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Otorhinolaryngologic Diseases
Neurologic Manifestations

Ear Diseases
Tinnitus
Ethanol
Acamprosate

Additional relevant MeSH terms:

Therapeutic Uses
Nervous System Diseases
Central Nervous System Agents
Pharmacologic Actions
Alcohol Deterrents

ClinicalTrials.gov processed this record on February 06, 2009