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The Effect of Gabapentin on the Sensation and Impact of Tinnitus

Primary Purpose

Tinnitus

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
gabapentin
Sponsored by
Tinnitus Research Consortium
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Chronic, Tinnitus, Acoustic trauma, Psychophysics, Loudness match, gabapentin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: non-pulsatile tinnitus present > 1 year Tinnitus Handicap Questionnaire score > 30 ability to perform psychophysical matching procedure Exclusion Criteria: evidence of depression renal insufficiency conductive hearing loss

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Psychophysical loudness match of tinnitus to broad band noise and pure tones.
    Subjective evaluation of tinnitus impact using Tinnitus Handicap Questionnaire.
    The subjective and objective measures were obtained after treatment with placebo and 4 doses of gabapentin.

    Secondary Outcome Measures

    Quality of Life survey (SF36-QOL)

    Full Information

    First Posted
    November 18, 2005
    Last Updated
    November 18, 2005
    Sponsor
    Tinnitus Research Consortium
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00257270
    Brief Title
    The Effect of Gabapentin on the Sensation and Impact of Tinnitus
    Official Title
    The Effect of Gabapentin on the Sensation and Impact of Tinnitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tinnitus Research Consortium

    4. Oversight

    5. Study Description

    Brief Summary
    This study evaluated the effectiveness of gabapentin in treating tinnitus in two populations: Tinnitus with associated acoustic trauma and tinnitus without associated acoustic trauma. The hypothesis was that gabapentin would decrease both subjective and objective features of tinnitus in the trauma group, but would be less effective in the non-trauma group.'
    Detailed Description
    Methods. A prospective, placebo-controlled, single-blind study of the effect of gabapentin on tinnitus was employed. Audiograms and personal histories were used to categorize tinnitus etiology as either secondary to acoustic trauma, or not associated with acoustic trauma. Participants were restricted to those with moderate-to-severe tinnitus for at least one year. All participants received gabapentin in a graduated ascending-descending dose series over 20 weeks (peak dose of 2400 mg/day). Results. There was a significant improvement in tinnitus annoyance for the trauma group (p = 0.05). Other subjective aspects of tinnitus were not significantly affected in either group. Between-subject variability of therapeutic response was considerable. Nevertheless, considering subjective loudness ratings, 4/19 non-trauma participants, and 6/20 trauma participants showed an improvement of 20 percent or better. Considering psychoacoustic loudness estimates, 4/19 non-trauma and 6/20 trauma participants showed a 15 dB (HL) improvement. Evenly dividing each group into high and low responders revealed significant improvement in loudness at 1800 and 2400 mg/day for the trauma high-response subgroup (p = 0.007). No significant improvement was obtained for other subgroups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tinnitus
    Keywords
    Chronic, Tinnitus, Acoustic trauma, Psychophysics, Loudness match, gabapentin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    Single
    Allocation
    Non-Randomized
    Enrollment
    40 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    gabapentin
    Primary Outcome Measure Information:
    Title
    Psychophysical loudness match of tinnitus to broad band noise and pure tones.
    Title
    Subjective evaluation of tinnitus impact using Tinnitus Handicap Questionnaire.
    Title
    The subjective and objective measures were obtained after treatment with placebo and 4 doses of gabapentin.
    Secondary Outcome Measure Information:
    Title
    Quality of Life survey (SF36-QOL)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: non-pulsatile tinnitus present > 1 year Tinnitus Handicap Questionnaire score > 30 ability to perform psychophysical matching procedure Exclusion Criteria: evidence of depression renal insufficiency conductive hearing loss
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carol Bauer, MD
    Organizational Affiliation
    Southern Illinois University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Gabapentin on the Sensation and Impact of Tinnitus

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