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The Effect of Gabapentin on the Sensation and Impact of Tinnitus

The Effect of Gabapentin on the Sensation and Impact of Tinnitus

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00257270
Enrollment
40
Registered
2005-11-22
Start date
2003-08-31
Completion date
2005-01-31
Last updated
2005-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Keywords

Chronic, Tinnitus, Acoustic trauma, Psychophysics, Loudness match, gabapentin

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.

Interventions

DRUGgabapentin

Sponsors

Tinnitus Research Consortium
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Quality of Life survey (SF36-QOL)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026