The Effect of Gabapentin on the Sensation and Impact of Tinnitus
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Tinnitus |
Drug: gabapentin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | The Effect of Gabapentin on the Sensation and Impact of Tinnitus |
- 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.
- Quality of Life survey (SF36-QOL)
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | January 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00257270 History of Changes |
| Other Study ID Numbers: | 03-073 |
| Study First Received: | November 18, 2005 |
| Last Updated: | November 18, 2005 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Tinnitus Research Consortium:
|
Chronic Tinnitus Acoustic trauma |
Psychophysics Loudness match gabapentin |
Additional relevant MeSH terms:
|
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 19, 2013