Ketamine for Tinnitus

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byDiana Martinez

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: New York State Psychiatric Institute

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Tinnitus, or ringing in the ears, is a very common problem that often accompanies hearing loss. It affects up to 1 in 10 adults, and about 30% of people who experience chronic tinnitus find it very distressing. In these patients, symptoms of depression and anxiety often accompany tinnitus and there are no approved treatments. Clinical trials are ongoing to test a glutamate NMDA receptor antagonist (called esketamine), which is injected into the inner ear. However, the preliminary results with this medication show that it only works for tinnitus that results from acute injury. It does not treat tinnitus resulting from progressive hearing loss. Research in humans and animals suggest that the neurotransmitters glutamate and GABA are important in the development and maintenance of tinnitus. This data shows that over-activation of the NMDA receptor and a decrease in GABA signaling in the brain play a crucial role. Previous studies show that ketamine, which an antagonist at the NMDA receptor, increases GABA levels in the brain in participants with depression. Thus, in this experiment, this study will test the effect of ketamine on tinnitus, since it blocks the NMDA glutamate receptor and increase GABA levels. Two groups of participants will be included in this study: those who experience distress (symptoms of anxiety or depression) with tinnitus and those who have tinnitus but do not experience distress. Each participant will receive both ketamine and placebo on different days. Magnetic Resonance Spectroscopy (MRS) scans will be

Research Team

Diana Martinez

Principal Investigator

NYSPI/Columbia University

Eligibility Criteria

Adults aged 21-60 with chronic tinnitus and mild sensorineural hearing loss for at least 6 months can join. Participants must experience distress, shown by certain scores on depression and anxiety scales, or have a significant handicap due to tinnitus. Pregnant individuals, those with serious medical conditions or psychiatric disorders (except mild-moderate depression/anxiety), history of recreational ketamine/PCP use, current psychotropic medication users, or people with metal implants cannot participate.

Inclusion Criteria

I am between 21 and 60 years old.

I have moderate to severe depression and some anxiety.

My tinnitus is severe enough to affect my daily life and can be masked by sounds over 5dB.

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Exclusion Criteria

I have a history of serious health issues like high blood pressure or heart disease.

You have metal implants or objects in your body that cannot be removed for scans.

Pregnancy, abortion, or lack of effective birth control during 15 days before the scan

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Treatment Details

Interventions

Ketamine Hydrochloride (NMDA Antagonist)
Saline (Drug)

Trial OverviewThe trial is testing Ketamine Hydrochloride's effect on tinnitus. It involves two groups: one distressed by tinnitus and the other not distressed but affected by it. Each participant will receive both ketamine and saline placebo in different sessions to compare effects. The study includes brain scans using Magnetic Resonance Spectroscopy to observe changes.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Tinnitus PatientsExperimental Treatment2 Interventions

Tinnitus patients are patients who do not experience symptoms of anxiety or depression with tinnitus. This group will receive both 0.5 mg/kg ketamine hydrochloride in saline and placebo, saline, with Magnetic Resonance Spectroscopy scans and audiometry testing and scales.

Group II: Tinnitus Distressed PatientsExperimental Treatment2 Interventions

Tinnitus distressed patients are patients who experience symptoms of anxiety or depression with tinnitus. This group will receive both 0.5 mg/kg ketamine hydrochloride in saline and placebo, saline, with Magnetic Resonance Spectroscopy scans and audiometry testing and scales.

Ketamine Hydrochloride is already approved in Canada for the following indications: