Nicotine Gum for Tinnitus

XW
Overseen ByXianhui Wang
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Xianhui Wang

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether nicotine gum affects brain responses to sounds in people with chronic tinnitus, a condition characterized by ringing in the ears. Participants will attend two sessions: one with nicotine polacrilex gum and another with placebo gum. Researchers will measure changes in brain activity and sound detection. The trial targets non-smoking adults who have experienced tinnitus for at least six months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that nicotine gum is generally safe to use. In a study involving over 3,000 people, nicotine gum caused no serious side effects or heart problems. Most participants experienced only mild issues such as hiccups, nausea, or a sore jaw. Another source mentions that side effects like heartburn or a sore throat can occur, but these are usually mild. Experts agree that the risk of addiction to nicotine gum is very low. Overall, nicotine gum is considered safe when used correctly.12345

Why do researchers think this study treatment might be promising for tinnitus?

Researchers are excited about nicotine gum for tinnitus because it offers a fresh approach compared to existing treatments like sound therapy or cognitive behavioral therapy. Unlike the standard care that typically focuses on managing symptoms, nicotine gum introduces a new active ingredient, nicotine polacrilex, which might affect neural pathways involved in tinnitus. This gum is also easy to use, offering a potentially convenient and fast-acting option. The idea of using a common product like nicotine gum for something as challenging as tinnitus is a novel twist that has researchers keen to see if it can make a difference.

What evidence suggests that nicotine gum might be an effective treatment for tinnitus?

This trial will compare the effects of nicotine gum with a placebo gum in adults with chronic tinnitus. Research has shown that nicotine can alter how the brain processes sounds. One study examined how a single dose of nicotine gum might affect these brain reactions in adults with chronic tinnitus, a constant ringing in the ears. Early results suggested that nicotine might change how the brain handles sounds, possibly affecting tinnitus symptoms. However, there is limited direct evidence that nicotine gum can reduce tinnitus symptoms. While nicotine can influence brain activity, more research is needed to determine its effectiveness for tinnitus. Prospective participants should consider the possible effects and consult a healthcare provider.678910

Who Is on the Research Team?

XW

Xianhui Wang

Principal Investigator

San Diego State University

Are You a Good Fit for This Trial?

This trial is for non-smoking adults who have chronic tinnitus (ringing or noise in the ears).

Inclusion Criteria

I am an adult who does not smoke and has not smoked in the past year.
I have had ongoing ringing in my ears for at least 6 months.

Exclusion Criteria

Current or recent tobacco or nicotine use
Pregnancy or breastfeeding
Any condition precluding the psychoacoustic tasks
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants attend two sessions, receiving a single 4 mg dose of nicotine polacrilex gum at one session and a placebo gum at the other, with EEG and auditory oddball task performance measured.

2 sessions over 1 week
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including EEG and auditory task performance.

Up to 2 hours post-administration per session

What Are the Treatments Tested in This Trial?

Interventions

  • Nicotine polacrilex gum

Trial Overview

The study tests if a single dose of nicotine gum affects brain responses to sounds and sound detection ability, compared to placebo gum. Each participant tries both gums in separate sessions, with neither they nor researchers knowing which is given each time.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Nicotine gum (4 mg)Experimental Treatment1 Intervention
Group II: Placebo gumPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Xianhui Wang

Lead Sponsor

San Diego State University

Lead Sponsor

Trials
182
Recruited
119,000+

Citations

Nicotine-Induced Osteonecrosis. A Case Report

This paper describes a previously unpublished side-effect of nicotine replacement chewing gum and presents useful information about the effects of nicotine ...

Seeking Advice From This Awesome Forum

Just purchased some Nicotine gum. I'll give this a go for a few weeks to see if the inflammation of the inner ear passes. This will - at least - ...

Evidence-Based Insights on Nicorette® Gum | PDF

The document discusses Evidence-based Medicine (EBM) on Nicotine Replacement Therapy (NRT), specifically focusing on Nicorette® Gum.

Study shows vaping beats gum, lozenges for quittin(...)

A new Australian clinical trial shows that vaping flavored nicotine liquids is significantly more effective for quitting smoking than ...

Zinc supplementation for tinnitus | Request PDF

Across these trials, zinc supplementation did not produce statistically significant improvements in tinnitus outcomes compared with placebo. ... ... However, ...

Acute Nicotine Gum and Tinnitus Loudness in Non- ...

This study tested whether a single dose of nicotine gum can reduce the loudness of tinnitus (ringing in the ears) in non-smoking adults with chronic tinnitus.

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/8620719/

Safety of nicotine polacrilex gum used by 3094 ... - PubMed

Conclusions: NP, as used in the Lung Health Study, appears to be safe and unrelated to any cardiovascular illnesses or other serous side effects. Publication ...

Nicotine Polacrilex Gum USP, 2 mg - accessdata.fda.gov

The experts at the workshop all agreed that the risk of abuse of these products is very low. After consideration of the Perrigo rationale and ...

Acute Nicotine Gum and Tinnitus Loudness... | Clinical Trial

This study tested whether a single dose of nicotine gum can reduce the loudness of tinnitus (ringing in the ears) in non-smoking adults with ...

Is Nicotine Gum Harmful to Your Health?

Lucchesi says that NRT products are highly safe and effective when used properly. Multiple studies have shown that using NRT nearly doubles a ...