What side effects are associated with this type of intervention?

Common treatments for tinnitus, particularly antidepressants and anxiolytics, can have various side effects. SSRIs (e.g., fluoxetine, sertraline) may cause nausea, diarrhea, insomnia, and sedation. SNRIs (e.g., venlafaxine, duloxetine) can lead to nausea, dry mouth, constipation, headache, dizziness, and insomnia. TCAs (e.g., amitriptyline) often cause sedation, dry mouth, and constipation. Anxiolytics like benzodiazepines may result in sedation, dizziness, and dependence. These side effects should be carefully considered and monitored by healthcare providers.

What prior FDA approvals exist?

Currently, there are no FDA-approved medications specifically for the treatment of tinnitus. However, pharmacological options such as antidepressants and anxiolytics are often used to manage the stress, anxiety, and depression associated with tinnitus. These medications can help improve the quality of life for patients by addressing the psychological and emotional impact of tinnitus. Commonly used antidepressants include SSRIs like fluoxetine and sertraline, and tricyclic antidepressants like amitriptyline, while anxiolytics may include medications such as benzodiazepines.

What other types of research exist?

Promising novel alternatives for tinnitus patients include: 1) Cognitive Behavioral Therapy (CBT), which has shown efficacy in reducing the distress caused by tinnitus. 2) Transtympanic infusion of lidocaine, which has been studied for its potential to alleviate tinnitus symptoms. 3) Intratympanic steroid injections, which have been used in cases of sudden hearing loss and may offer relief for tinnitus. 4) Peer-led programs and support groups, which can provide coping strategies and emotional support. These alternatives focus on reducing the impact of tinnitus on daily life and improving overall quality of life.

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Tricyclic Antidepressant + Anticonvulsant

Migraine Medications for Tinnitus

Phase 4

Recruiting

Led By Hamid R Djalilian, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial tests two different medication combinations to help people with tinnitus. One group gets nortriptyline and topiramate, another gets verapamil and paroxetine. The goal is to see if these medications can reduce the stress and anxiety caused by tinnitus. Paroxetine has been studied previously for its potential to relieve tinnitus symptoms.

Who is the study for?

This trial is for adults aged 25-85 with moderate to severe tinnitus. Participants must be able to read and write English, attend study visits, and comply with medication regimens. Pregnant individuals, those with adverse reactions to the medications being tested or certain medical conditions are excluded.

What is being tested?

The trial tests if migraine medications can help treat tinnitus. It compares the effectiveness of Nortriptyline plus Topiramate versus Verapamil plus Paroxetine against a placebo in reducing the impact of tinnitus on daily life.

What are the potential side effects?

Potential side effects may include dry mouth, constipation, weight changes from Nortriptyline; numbness or tingling from Topiramate; low blood pressure or dizziness from Verapamil; and nausea or sleep disturbances from Paroxetine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tinnitus Functional Index (TFI)

Secondary study objectives

Patient Health Questionnaire (PHQ)

Perceived Stress Scale (PSS)

Sleep Quality Index (SQI)

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Verapamil + paroxetineExperimental Treatment1 Intervention

Verapamil (30 mg) plus paroxetine (4 mg) in a single pill initially taken once daily. Dose may be increased as directed by care provider by 30mg weekly (to a maximum of 240mg) for verapamil, and by 4mg weekly (maximum 32mg) for paroxetine.

Group II: Nortriptyline + topiramateExperimental Treatment1 Intervention

Nortriptyline (7.5 mg) plus topiramate (10 mg) in a single pill initially taken once daily. Dose may be increased as directed by care provider by 7.5mg weekly (to a maximum of 60mg) for nortriptyline, and by 10mg weekly (maximum 80mg) for topiramate.

Group III: PlaceboPlacebo Group1 Intervention

Placebo pill.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for tinnitus, particularly antidepressants and anxiolytics, work by addressing the psychological distress that often accompanies the condition. Antidepressants, such as SSRIs and SNRIs, function by increasing the levels of neurotransmitters like serotonin and norepinephrine in the brain, which can improve mood and reduce anxiety. Anxiolytics, such as benzodiazepines, enhance the effect of the neurotransmitter GABA, leading to a calming effect on the nervous system. These mechanisms are crucial for tinnitus patients as they help alleviate the emotional and psychological burden of tinnitus, thereby improving their overall quality of life.