Nicotine Gum for Hearing Impairment

(Nicotine Trial)

Overseen By Fan-Gang Zeng

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Must not be taking: Prescription medications

Disqualifiers: Deafness, Psychiatric illness, Neurological disorders, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 sessions

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether nicotine gum, a form of nicotine replacement therapy, can improve hearing in individuals affected by aging. Researchers aim to determine if nicotine can reverse some negative effects of aging on auditory processing, which is how the brain interprets sounds. Participants will chew either nicotine gum or a placebo gum that looks and tastes the same. Ideal candidates are non-smokers aged 18 to 85 with mild hearing issues, who are not deaf and do not take regular prescription medications.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatments for age-related hearing loss.

Will I have to stop taking my current medications?

Yes, you will need to stop taking regular prescription medications, except for oral contraceptives, to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that nicotine gum is generally safe for use. It helps people quit smoking by easing withdrawal symptoms. Typically, users chew nicotine gum for about 30 minutes, as instructed. This product is available without a prescription and is safe for most adults, though it can cause some side effects.

Common side effects include hiccups, nausea, or a sore jaw. These effects are usually mild and resolve quickly. Nicotine gum is not recommended for certain individuals, such as pregnant women or those with specific health issues. However, for most adults, using nicotine gum as directed is generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for hearing impairment, which typically involve hearing aids or cochlear implants, nicotine gum offers a novel approach by potentially enhancing auditory function through its active ingredient, nicotine. Researchers are intrigued by nicotine's ability to increase neurotransmitter activity, which may improve hearing by affecting the auditory pathways in the brain. This gum is also non-invasive and easy to use, providing a convenient alternative that could complement or offer benefits beyond current hearing solutions.

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

Research shows that nicotine might aid hearing by enhancing the brain's sound processing. One study demonstrated that nicotine significantly improved the ability to hear tones in noisy environments and focus on specific sounds. Another study found that nicotine helped the brain ignore unimportant sounds, making it easier to concentrate on important ones. This trial will compare nicotine gum, which participants may receive, with placebo gum. These findings suggest that nicotine gum could enhance hearing by improving sound processing, especially in challenging listening situations. ^{2 3 6 7 8}

Who Is on the Research Team?

Fan-Gang Zeng, PhD

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

This trial is for non-smoking adults aged 18-85 with mild hearing issues and normal cognitive function. It's not for those who are deaf, have severe hearing loss, take regular prescription meds (except birth control), have a history of drug dependency or certain health conditions like heart disease or diabetes.

Inclusion Criteria

Non-smokers with a Fagerström index of smoking dependency score of 0-2 out of 10

Cognitive performance within two standard deviations of the CERAD mean

Exclusion Criteria

Smokers with a Fagerström index of smoking dependency score between 3 and 10

I have a history of mental health issues, nerve disorders, diabetes, kidney failure, or heart disease.

I regularly take prescription medications, not including birth control pills.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nicotine or placebo gum in a double-blind, cross-over design across two sessions

2 sessions

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine gum
• Placebo gum

Trial Overview The study tests if nicotine gum can help older adults hear better by improving how their brains process sounds. Participants will chew either nicotine gum or a placebo gum without active ingredients to see if there's any difference in their hearing abilities.

How Is the Trial Designed?

Group I: Nicotine gum Experimental Treatment 1 Intervention

Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication

Group II: Placebo gum Placebo Group 1 Intervention

The placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture.

Nicotine gum is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Nicotine gum for:

• Smoking cessation

Approved in European Union as Nicotine gum for:

• Smoking cessation

Approved in Canada as Nicotine gum for:

• Smoking cessation

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study of 32 patients with medically unexplained physical symptoms (MUPS) attributed to dental amalgam, removal of amalgam fillings led to a significant decrease in serum levels of inorganic mercury (I-Hg) and silver (Ag) after one year.

Although the intensity of health complaints decreased following the removal of amalgam restorations, there was no direct correlation found between the levels of mercury or silver in the blood and the reported health issues, suggesting that other factors may also contribute to these symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mercury, silver and selenium in serum before and after removal of amalgam restorations: results from a prospective cohort study in Norway. Björkman, L., Musial, F., Alræk, T., et al.[2023]

Targeting the α9α10 nicotinic acetylcholine receptor (nAChR) could be a promising strategy to prevent noise-induced hearing loss and delay age-related hearing loss (presbycusis), as this receptor plays a crucial role in protecting cochlear outer hair cells from damage.

The development of positive allosteric modulators for α9α10 nAChRs is suggested, as they can enhance the natural protective signaling without overstimulating the receptors, which could lead to desensitization and reduced effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The α9α10 nicotinic acetylcholine receptor: a compelling drug target for hearing loss? Elgoyhen, AB.[2023]

In a study involving rats anesthetized with pentobarbital, nicotine administration (100 micrograms/kg) did not significantly affect the latencies of brainstem auditory evoked responses (FFP) or electrocochleography (EcoG) components.

However, nicotine significantly increased the amplitude of certain FFP components (I, I', II, and III) after 30 minutes, indicating that it may have both muscarinic and nicotinic effects on the brainstem auditory pathway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of nicotine on auditory functions in the rat, studied by electrocochleography and auditory evoked potentials of the brain stem]. de Lavernhe-Lemaire, MC., Garand, G.[2015]

Cention N in SelfCure mode demonstrated superior mechanical properties, including the highest flexural strength (82.94 MPa) and lowest surface roughness (0.13 μm) compared to other materials tested, indicating its potential for better performance in dental restorations.

When used with an adhesive, Cention N SelfCure showed significantly reduced microleakage compared to other groups, suggesting improved sealing ability and effectiveness in preventing leakage in dental applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of physical and mechanical properties of three different restorative materials in primary teeth: an in vitro study. Keskus, B., Oznurhan, F.[2022]

In a study involving 20 normal-hearing non-smokers, transdermal nicotine did not significantly impact cochlear activity, as measured by otoacoustic emissions.

However, nicotine administration did affect neural transmission in the auditory pathway, leading to increased latency and decreased amplitude in wave I of the auditory brainstem response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effect of nicotine on non-smokers: I. OAEs and ABRs. Harkrider, AW., Champlin, CA., McFadden, D.[2019]

The study found that exposure to certain mouthrinses significantly softened composite and compomer dental materials, with Dyract being notably softened by Listerine Original and Esthet-X softened by both Listerine Original and Colgate Chloropharm.

Wear resistance was also affected, as Dyract showed reduced wear resistance after exposure to Oral B Sensitive, while Esthet-X's wear resistance decreased with Colgate Chloropharm, indicating that the impact of mouthrinses varies depending on the dental material used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of mouthrinses on microhardness and wear of composite and compomer restoratives. Yap, AU., Tan, BW., Tay, LC., et al.[2022]

A systematic review of 52 studies on glass-ionomer restoratives found no conclusive evidence that these materials effectively inhibit secondary caries at restoration margins, as results were evenly split between positive and negative outcomes.

The review highlighted the need for better clinical evaluation methods and more robust randomized controlled trials to accurately assess the efficacy of glass-ionomer restoratives in preventing secondary caries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glass-ionomer restoratives: a systematic review of a secondary caries treatment effect. Randall, RC., Wilson, NH.[2022]

High doses of nicotine, both administered intravenously and intracochlearly, had minimal impact on cochlear potentials in guinea pigs, suggesting low ototoxicity at these levels.

Chronic nicotine treatment over 20 days did not affect cochlear potentials or hair cell damage, indicating that nicotine does not cause harm to the auditory system under the conditions tested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of nicotine on cochlear function and noise-induced hair cell loss. Bobbin, RP., Gondra, MI.[2017]

In a survey of 60 patients who underwent dental amalgam replacement and detoxification treatment, 78% reported satisfaction with their symptom improvement, particularly for headaches and backaches, indicating the treatment's efficacy.

The most common distressing symptoms before treatment included memory issues, muscle pain, and anxiety, highlighting the diverse health concerns addressed by the detoxification protocol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of dental amalgam removal and mercury detoxification using DMPS and neural therapy. Kidd, RF.[2014]

Nicotine exposure in adult male guinea pigs leads to significant damage in the cochlea, particularly affecting the outer hair cells, which are crucial for hearing.

Higher doses of nicotine (6 mg/kg) resulted in more severe cellular damage, including distortion and blebbing of hair cells, especially in the basal turn of the cochlea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of nicotine on the structure of cochlea of guinea pigs. Abdel-Hafez, AM., Elgayar, SA., Husain, OA., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7039769/

Nicotine Enhances Auditory Processing in Healthy and ... Nicotine significantly improved performance in the more difficult tasks of tone-in-noise detection and selective attention.

2. nature.com nature.com/articles/s41598-021-92588-z

Task-dependent effects of nicotine treatment on auditory ... These results suggest that nicotine aids with auditory gating in order to facilitate processing of relevant sounds while filtering out irrelevant sounds.

3. withpower.com withpower.com/trial/phase-7-2021-16b33

Nicotine Gum for Hearing Impairment (Nicotine Trial) This trial will test if chewing nicotine gum can help improve hearing in young and older adults by enhancing how the brain processes sounds.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9948942/

A qualitative analysis of nicotine replacement therapy ... This study examines qualitative data collected as part of a research program to develop and pilot test a proactive smoking cessation intervention with text ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04971954/using-nicotine-to-reverse-age-related-auditory-processing-deficits

Using Nicotine to Reverse Age-related Auditory Processing ... The present study will evaluate the effects of both aging and nicotine on psychophysical tasks and electrophysiological measures.

6. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/n/NicotrolGum.pdf

Data Sheet Could be used as a single treatment or in combination with nicotine patch. Each piece of Nicotrol gum should be chewed intermittently for about 30 minutes.

7. webmd.com webmd.com/drugs/2/drug-75256-746/nicotine-polacrilex-buccal/nicotine-lozenge-buccal/details

Nicotine (NicoDerm, Nicorette, and others) - Uses, Side ... Nicotine is used to help reduce withdrawal symptoms from quitting smoking. Common side effects vary based on the form of nicotine that you use.

8. cancer.org cancer.org/cancer/risk-prevention/tobacco/guide-quitting-smoking/nicotine-replacement-therapy.html

Nicotine Replacement Therapy to Help You Quit Tobacco *NRT is not approved for pregnant women or teens. It also might not be safe for adults with certain other health problems. How does nicotine ...