Completed

Gabapentin's Impact on Tinnitus Annoyance and Loudness

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What is being tested

Data Collection

Who is being recruted

Bronchiolitis Obliterans Syndrome+20

+ Organizing Pneumonia

+ Bronchial Diseases

From 18 to 75 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2003
See protocol details

Summary

Principal SponsorTinnitus Research Consortium
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2003

Actual date on which the first participant was enrolled.

This study explores the effects of a drug called Gabapentin on tinnitus, a condition where a person experiences ringing or buzzing in the ears. The study focuses on individuals who have had moderate to severe tinnitus for at least a year, with the cause being either related to acoustic trauma or not. The main goal is to understand if Gabapentin can help reduce the annoyance and impact of tinnitus, potentially improving the quality of life for those affected by this condition. During the study, all participants receive Gabapentin in increasing and then decreasing doses over a period of 20 weeks, with the highest dose being 2400 mg per day. The study measures the loudness of tinnitus and its impact on daily life using audiograms and a questionnaire called the Tinnitus Handicap Questionnaire. These measurements are taken after treatment with a placebo and four different doses of Gabapentin. The results show a significant improvement in tinnitus annoyance for those with acoustic trauma. However, the response to treatment varies greatly among participants.

Official TitleThe Effect of Gabapentin on the Sensation and Impact of Tinnitus
Principal SponsorTinnitus Research Consortium
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchiolitis Obliterans SyndromeOrganizing PneumoniaBronchial DiseasesBronchiolitisBronchiolitis ObliteransBronchitisEar DiseasesGraft vs Host DiseaseHearing DisordersHearing Loss, Noise-InducedHearing Loss, SensorineuralImmune System DiseasesLung DiseasesLung Diseases, ObstructiveNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesRespiratory Tract DiseasesSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsTinnitusHearing Loss

Criteria

3 inclusion criteria required to participate
non-pulsatile tinnitus present > 1 year

Tinnitus Handicap Questionnaire score > 30

ability to perform psychophysical matching procedure

3 exclusion criteria prevent from participating
renal insufficiency

evidence of depression

conductive hearing loss

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers