Nicotine Gum for Hearing Impairment

(Nicotine Trial)

Overseen By Mac Morrison

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 will test if chewing nicotine gum can help improve hearing in young and older adults by enhancing how the brain processes sounds. Nicotine has been commonly used in studies, showing its benefits on mental performance.

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 nicotine gum safe for humans?

Research on nicotine, the main component of nicotine gum, shows that it generally does not harm the cochlea (inner ear) in guinea pigs at certain doses, but high doses can damage ear cells. In humans, nicotine does not significantly affect cochlear activity but can alter neural transmission of sound. ^{1 2 3 4 5}

How does nicotine gum differ from other treatments for hearing impairment?

Nicotine gum is unique for hearing impairment as it is primarily known for helping people quit smoking by providing a controlled dose of nicotine to reduce withdrawal symptoms, unlike other treatments for hearing issues which may focus on hearing aids or surgical interventions. This approach is novel because it explores the potential effects of nicotine on hearing, which is not a standard treatment for hearing impairment. ^{6 7 8 9 10}

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Effect of nicotine on cochlear function and noise-induced hair cell loss. [2017]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of nicotine on the structure of cochlea of guinea pigs. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Acute effect of nicotine on non-smokers: I. OAEs and ABRs. [2019]

5. Belgium 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]. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of mouthrinses on microhardness and wear of composite and compomer restoratives. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Glass-ionomer restoratives: a systematic review of a secondary caries treatment effect. [2022]

10. England 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. [2023]