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The Effect of Gabapentin on the Sensation and Impact of Tinnitus

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ClinicalTrials.gov Identifier: NCT00257270
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : November 22, 2005
Sponsor:
Information provided by:
Tinnitus Research Consortium

Study Description
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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.'

Condition or disease Intervention/treatment Phase
Tinnitus Drug: gabapentin Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Effect of Gabapentin on the Sensation and Impact of Tinnitus
Study Start Date : August 2003
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Psychophysical loudness match of tinnitus to broad band noise and pure tones.
  2. Subjective evaluation of tinnitus impact using Tinnitus Handicap Questionnaire.
  3. The subjective and objective measures were obtained after treatment with placebo and 4 doses of gabapentin.

Secondary Outcome Measures :
  1. Quality of Life survey (SF36-QOL)

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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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): NCT00257270


Sponsors and Collaborators
Tinnitus Research Consortium
Investigators
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Principal Investigator: Carol Bauer, MD Southern Illinois University School of Medicine
More Information
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ClinicalTrials.gov Identifier: NCT00257270    
Other Study ID Numbers: 03-073
First Posted: November 22, 2005    Key Record Dates
Last Update Posted: November 22, 2005
Last Verified: June 2005
Keywords provided by Tinnitus Research Consortium:
Chronic
Tinnitus
Acoustic trauma
 Psychophysics
Loudness match
gabapentin
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents