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NMDA Antagonist

Ketamine for Tinnitus

Phase 2
Waitlist Available
Led By Diana Martinez
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tinnitus associated with at least mild sensori-neural hearing loss of at least 6 months duration
Participant aged 21-60
Must not have
Presence or positive history of significant medical or neurological illness, including high blood pressure (SBP >140, DBP > 90), cardiac illness, abnormality on EKG, head injury
History of recreational ketamine use, recreational PCP use, exposure to ketamine as an anesthetic, or an adverse reaction to ketamine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, pre and post ketamine and placebo sessions, daily for 10 days after the sessions
Awards & highlights

Summary

This trial is testing if ketamine, an antagonist at the NMDA receptor, can help treat tinnitus by increasing GABA levels in the brain. So far, it only works for tinnitus that results from acute injury, not from progressive hearing loss.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Ketamine may cause side effects such as dizziness, nausea, increased heart rate, euphoria, disorientation, visual disturbances and potentially an increase in depressive symptoms after the initial improvement wears off.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had ringing in my ears and some hearing loss for over 6 months.
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I am between 21 and 60 years old.
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I have moderate to severe depression and some anxiety.
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My tinnitus is severe enough to affect my daily life and can be masked by sounds over 5dB.
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I have moderate to severe depression and some anxiety.
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My tinnitus is caused by hearing loss, not another medical condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of serious health issues like high blood pressure or heart disease.
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I have used ketamine recreationally, as an anesthetic, or had a bad reaction to it.
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I am currently on medication for mental health issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, pre and post ketamine and placebo sessions, then daily
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, pre and post ketamine and placebo sessions, then daily for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in GABA and Glutamate (Glx) levels in the auditory cortex derived from 3T Magnetic Resonance Spectroscopy
Secondary outcome measures
Change in Profile of Mood States (POMS)
Change in The Brief Psychiatric Rating Scale (BPRS)
Change in The Tinnitus Handicap Inventory (THI)
+2 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Saline
2013
Completed Phase 4
~2110

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,613 Total Patients Enrolled
Diana MartinezPrincipal Investigator - NYSPI/Columbia University
New York State Psychiatric Institute

Media Library

Ketamine Hydrochloride (NMDA Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03336398 — Phase 2
Tinnitus Research Study Groups: Tinnitus Distressed Patients, Tinnitus Patients
Tinnitus Clinical Trial 2023: Ketamine Hydrochloride Highlights & Side Effects. Trial Name: NCT03336398 — Phase 2
Ketamine Hydrochloride (NMDA Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03336398 — Phase 2
Tinnitus Patient Testimony for trial: Trial Name: NCT03336398 — Phase 2
~7 spots leftby Jul 2025
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