Nicotine Gum for Hearing Impairment
(Nicotine Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Irvine
Must not be taking: Prescription medications
Disqualifiers: Deafness, Psychiatric illness, Neurological disorders, others
Approved in 3 Jurisdictions
Trial Summary
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.
12345How 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.
678910Eligibility Criteria
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
I am between 18 and 85 years old.
Exclusion Criteria
I am younger than 18 or older than 85.
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.
+3 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nicotine gumExperimental Treatment1 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 gumPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hearing and Speech LabIrvine, CA
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Who Is Running the Clinical Trial?
University of California, IrvineLead Sponsor
National Institute on Aging (NIA)Collaborator
References
The α9α10 nicotinic acetylcholine receptor: a compelling drug target for hearing loss? [2023]Hearing loss is a major health problem, impacting education, communication, interpersonal relationships, and mental health. Drugs that prevent or restore hearing are lacking and hence novel drug targets are sought. There is the possibility of targeting the α9α10 nicotinic acetylcholine receptor (nAChR) in the prevention of noise-induced, hidden hearing loss and presbycusis. This receptor mediates synaptic transmission between medial olivocochlear efferent fibers and cochlear outer hair cells. This target is key since enhanced olivocochlear activity prevents noise-induced hearing loss and delays presbycusis.
Effect of nicotine on cochlear function and noise-induced hair cell loss. [2017]Nicotine administered in high doses intravenously (1 mg/kg) and intracochlearly (10 mM) exhibited very little effect on guinea pig cochlear potentials. When administered chronically (1-20 mg/kg, i.p. for 20 days), nicotine demonstrated no effect on cochlear potentials or the number of observed hair cell scars monitored 21 days after the treatment was terminated. Neither chronic nicotine treatment (1-20 mg/kg, i.p. for 20 days) nor acute reserpine pretreatment (5 mg/kg, i.p. 24 hours before) altered the hair cell damaging effects of an intense pure tone (4 kHz, 126 dB SPL, 30 min). No nicotine ototoxicity was detected by the methods used in this study.
Effect of nicotine on the structure of cochlea of guinea pigs. [2021]Smoking has been positively associated with hearing loss in human. However, its effect on the cochlea has not been previously evaluated. Aim of work is to investigate the effect of nicotine, which is the primary pharmacological component of tobacco, on the structure of the cochlea of adult male guinea pigs. Fifteen male guinea pigs were classified into two groups: group I (control) and group II (nicotine treated group). Group II was further subdivided into two subgroups; IIA and IIB according to the dose of nicotine (3 mg/kg and 6 mg/kg, respectively). The cochlea was harvested and processed for light microscopy, transmission electron microscopy and scanning electron microscopy. Nicotine administration induced damage of outer hair cells which were distorted in shape with vacuolated cytoplasm and heterochromatic nuclei. Topography revealed damage of the stereocilia which included disorganization, bent and limp or complete loss and expansion of the surrounding supporting cells. These changes were more pronounced in the basal turn of the cochlea and mainly involved the outer hair cells. High dose induced more damage and resulted in protrusion of the apical poles of hair cells (blebing), particularly the outer two rows. Nicotine is proved to be harmful to the cells of the cochlea, particularly the outer hair cells of the basal turn. High doses induce blebing of hair cells.
Acute effect of nicotine on non-smokers: I. OAEs and ABRs. [2019]This paper is the first in a series of three investigating the role of cholinergic mechanisms in the auditory system by assessing the acute effects of nicotine, an acetylcholinomimetic drug, on aggregate responses within the auditory pathway. In a single-blind procedure, auditory responses were obtained from 20 normal-hearing, non-smokers (10 male) under two conditions (nicotine, placebo). After the drug session, plasma tests revealed a subject's nicotine concentration. The effects of nicotine on early, exogenous responses of the auditory system (otoacoustic emissions and auditory brainstem potentials) are described in this first paper. Results indicated that transdermal administration of nicotine to non-smokers does not significantly affect cochlear activity but does acutely affect the neural transmission of acoustic information. Overall, otoacoustic emissions were unaffected by transdermal nicotine while wave I of the auditory brainstem response was significantly increased in latency and decreased in amplitude.
[Effect of nicotine on auditory functions in the rat, studied by electrocochleography and auditory evoked potentials of the brain stem]. [2015]The rôle of nicotine (100 micrograms/kg) on brainstem auditory evoked responses (FFP) and electrocochleography (EcoG) in rats anaesthetized with pentobarbital has been studied. Each component of FFP and EcoG was analysed in terms of its latency and amplitude. Nicotine failed to produce any significant changes in the latencies of the FFP and EcoG components. Nicotine after 30 min increases significantly the amplitude I, I', II and III, of the FFP components, and decreases no significantly IV and V components. These finding suggests the presence of muscarinic and nicotinic effect of nicotine, in the mediation of the brainstem auditory pathway.
Effect of mouthrinses on microhardness and wear of composite and compomer restoratives. [2022]This study investigated the effect of commercially available mouthrinses on the microhardness and wear of composite (Esthet-X, Dentsply) and compomer (Dyract Posterior, Dentsply) restoratives. Fifty-four hardness and 36 wear specimens of each material were fabricated and stored in distilled water at 37 degrees C for two weeks. The specimens were then randomly divided into six equal groups and exposed to the following solutions for 24 hours at 37 degrees C: distilled water [WC] (control); Listerine Original [AP] (alcohol-containing essential oil/phenolic compound mouthrinse); Colgate Chloropharm [AC] (alcohol-containing chlorhexidine mouthrinse); Oral B Tooth & Gum Care [AF] (alcohol-containing fluoride mouthrinse); Oral B Tooth & Gum Care Alcohol Free [OF] (alcohol free fluoride mouthrinse) and Oral B Sensitive [PF] (phosphoric acid containing fluoride mouthrinse). After conditioning, the specimens were subjected to hardness testing using a digital microhardness tester (load = 500 gf; dwell time = 15 seconds) and wear testing with a reciprocal compression-sliding system (contact stress = 20 MPa). Wear depth was measured every 1,000 cycles up to 10,000 cycles using profilometry. Data was analyzed using ANOVA/Scheffe's test at significance level 0.05. Dyract was significantly softened by AP, while Esthet-X was significantly softened by AC and AP. The wear resistance of Dyract was significantly reduced after exposure to PF, while the wear resistance of Esthet-X was significantly reduced by AC. The effect of mouthrinses on hardness and wear was material dependent.
Results of dental amalgam removal and mercury detoxification using DMPS and neural therapy. [2014]Sixty consecutive patients who had undergone replacement of dental amalgam fillings and a protocol of nutritional support and heavy metal detoxification using dimercapto-propanyl-sulfate and neural therapy were surveyed. A questionnaire was mailed to the patients and 42 responded, resulting in a response rate of 70%. The reasons for undergoing treatment were many, ranging from a patient's desire to avoid potential health problems in the future to treatment of serious current disease. Although medical diagnoses were made when possible before treatment, this survey studied only the patients' estimations of their most distressing symptoms and their evaluations of response to treatment. The most common complaints were problems with memory and/or concentration; muscle and/or joint pain; anxiety and insomnia; stomach, bowel, and bladder complaints; depression; food or chemical sensitivities; numbness or tingling; and eye symptoms, in descending order of frequency. The most distressing symptoms were headache and backache, fatigue, and memory and concentration problems. Headache and backache responded best to treatment, but all symptoms showed considerable improvement on average. Of the respondents, 78% reported that they were either satisfied or very satisfied with the results of treatment, and 9.5% reported that they were disappointed.
Comparison of physical and mechanical properties of three different restorative materials in primary teeth: an in vitro study. [2022]Physical and mechanical properties of three different (Ketac Molar Easymix, Dyract XP, Cention N (CN)) restoratives with different ingredients were evaluated.
Glass-ionomer restoratives: a systematic review of a secondary caries treatment effect. [2022]It is generally accepted that glass ionomers inhibit secondary caries in vivo, and data from in vitro studies support this effect. The aim of this review was a systematic assessment, from the literature, of clinical evidence for the ability of glass-ionomer restoratives to inhibit secondary caries at the restoration margin. Inclusion and exclusion criteria for selection of the review papers were established prior to commencement of the literature search. Papers which conformed to these criteria, and reported on secondary caries as an outcome, were selected (N = 52). Primary and secondary lists of systematic criteria for use in the assessment of the papers were drawn up. The primary list of 14 criteria was applied to each paper. No paper fulfilled all these criteria, necessitating the use of the secondary measures: (i) a prospective study and (ii) use of an appropriate control. This yielded 28 papers. Tabulation of these papers by occurrence of secondary caries in the glass-ionomer or control groups demonstrated an even distribution between positive and negative outcomes. Valid evidence is considered to be best obtained from randomized, controlled studies of sufficient sample size. No conclusive evidence for or against a treatment effect of inhibition of secondary caries by the glass-ionomer restoratives was obtained from the systematic review. There is a need for appraisal of the methods currently adopted for the clinical evaluation of glass-ionomer restorative materials, and for further development of the methodology to support future systematic reviews.
Mercury, silver and selenium in serum before and after removal of amalgam restorations: results from a prospective cohort study in Norway. [2023]A prospective cohort study on changes of health complaints after removal of amalgam restorations was carried out at the request of the Norwegian Directorate of Health. The aim was to provide and evaluate experimental treatment to patients with health complaints attributed to dental amalgam fillings.