The Effect of Gabapentin on the Sensation and Impact of Tinnitus

This study has been completed.
Sponsor:
Information provided by:
Tinnitus Research Consortium
ClinicalTrials.gov Identifier:
NCT00257270
First received: November 18, 2005
Last updated: NA
Last verified: June 2005
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Tinnitus Research Consortium:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Quality of Life survey (SF36-QOL)

Estimated Enrollment: 40
Study Start Date: August 2003
Estimated Study Completion Date: January 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257270

Sponsors and Collaborators
Tinnitus Research Consortium
Investigators
Principal Investigator: Carol Bauer, MD Southern Illinois University School of Medicine
  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 September 16, 2014