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Completed

NCT Number: NCT00257270

The Effect of Gabapentin on the Sensation and Impact of Tinnitus

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.'

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Key information

Conditions

Tinnitus Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Ear Diseases Graft vs Host Disease Hearing Disorders Hearing Loss Hearing Loss, Noise-Induced Hearing Loss, Sensorineural Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Neurologic Manifestations Organizing Pneumonia Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Sensation Disorders Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

Primary outcomes

  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 outcomes

  1. Quality of Life survey (SF36-QOL)

Sponsors and collaborators

Lead sponsor

Tinnitus Research Consortium

Other

Registry information

Important dates

Study start
2003
Study completion
2005
First posted
Nov 22, 2005
Registry last updated
Nov 22, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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