48 Participants Needed

Nicotine Gum for Hearing Impairment

(Nicotine Trial)

MK
MM
Overseen ByMac Morrison
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

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.678910

Who Is on the Research Team?

FZ

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.
See 2 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nicotine gumExperimental Treatment1 Intervention
Group II: Placebo gumPlacebo Group1 Intervention

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

🇺🇸
Approved in United States as Nicotine gum for:
🇪🇺
Approved in European Union as Nicotine gum for:
🇨🇦
Approved in Canada as Nicotine gum for:

Find a Clinic Near You

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

Citations

The α9α10 nicotinic acetylcholine receptor: a compelling drug target for hearing loss? [2023]
Effect of nicotine on cochlear function and noise-induced hair cell loss. [2017]
Effect of nicotine on the structure of cochlea of guinea pigs. [2021]
Acute effect of nicotine on non-smokers: I. OAEs and ABRs. [2019]
[Effect of nicotine on auditory functions in the rat, studied by electrocochleography and auditory evoked potentials of the brain stem]. [2015]
Effect of mouthrinses on microhardness and wear of composite and compomer restoratives. [2022]
Results of dental amalgam removal and mercury detoxification using DMPS and neural therapy. [2014]
Comparison of physical and mechanical properties of three different restorative materials in primary teeth: an in vitro study. [2022]
Glass-ionomer restoratives: a systematic review of a secondary caries treatment effect. [2022]
Mercury, silver and selenium in serum before and after removal of amalgam restorations: results from a prospective cohort study in Norway. [2023]
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