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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
Participant aged 21-60
Tinnitus associated with at least mild sensori-neural hearing loss of at least 6 months duration
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
No Placebo-Only Group

Study 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 am between 21 and 60 years old.
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I have had ringing in my ears and some hearing loss for at least 6 months.
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My tinnitus is caused by hearing loss, not another disease.
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I have moderate to severe depression and some anxiety.
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I am between 21 and 60 years old.
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I have had ringing in my ears and some hearing loss for over 6 months.
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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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My tinnitus is caused by hearing loss, not another medical condition.
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I have moderate to severe depression and some anxiety.
Select...
My tinnitus is caused by hearing loss, not another disease.
Select...
I am between 21 and 60 years old.
Select...
I have had ringing in my ears and some hearing loss for at least 6 months.
Select...
My tinnitus is severe enough to affect my daily life and hearing tests confirm it.
Select...
My tinnitus is caused by hearing loss, not another disease.
Select...
I have moderate to severe depression and some anxiety.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1050

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
472 Previous Clinical Trials
153,013 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment seek out participants in the senior age range?

"Consistent with its inclusion criteria, the lower limit for enrollment in this trial is 21 and no patient may be older than 60."

Answered by AI

Is the use of Ketamine Hydrochloride diluted in saline sanctioned by the FDA?

"Our in-house team at Power assessed the safety of Ketamine Hydrochloride in saline as a 2, since this is currently a Phase 2 clinical trial with some evidence to suggest it's safe but none to indicate its efficacy."

Answered by AI

Are medical professionals currently recruiting participants for this trial?

"Affirmative. Clinicaltrials.gov's records indicate that the trial, first posted on September 1st 2019, is currently accepting patients and plans to recruit 40 individuals from 2 sites."

Answered by AI

Is my eligibility sufficient to partake in the experiment?

"This clinical trial, which is open to those between 21 and 60 years of age suffering from tinnitus, seeks 40 participants. To qualify for the study they must have a score of 14 or more on the Hamilton Depression Rating Scale with an anxiety rating of at least 2 (in the distressed group), a Tinnitus Handicap Inventory rating greater than 32, masked hearing loss above 5dB as well as sensori-neural hearing impairment lasting 6 months or longer that isn't related to medical disease."

Answered by AI

How many participants are eligible to join this clinical experiment?

"Affirmative. On clinicaltrials.gov, the information confirms that this trial which was initially posted on September 1st 2019 is now actively recruiting patients. Approximately 40 participants are being sought from 2 different medical sites."

Answered by AI

Who else is applying?

What state do they live in?
Texas
New Jersey
New York
Other
How old are they?
65+
18 - 65
What site did they apply to?
1051 Riverside Drive
New York State Psychiatric Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

What questions have other patients asked about this trial?

How many visits are required ? How many visits will be required? How many times will I need to be onsite in New York?
PatientReceived 1 prior treatment
How long does the trials could take or How many times is it expected the need to travel ?
PatientReceived no prior treatments

Why did patients apply to this trial?

TINITUS IS A BURDEN. i have loud tinnitus. I’ve had tinnitus quite awhile and am seeking help.
PatientReceived 2+ prior treatments
I would like to find a solution for tinnitus relief for myself and others.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
~8 spots leftby Feb 2025