Nicotine Gum for Aging-Related Hearing Improvement

Overseen By Michael A Silver, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, Berkeley

Must not be taking: Prescription medications

Disqualifiers: Hearing loss, Smoking, Psychiatric illness, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

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 enhance hearing in older adults by boosting the brain's ability to focus on important sounds, such as understanding speech in noisy environments. Researchers will examine brain activity using special imaging (fMRI) to observe how nicotine affects hearing. They will compare results between younger and older participants, using both nicotine gum and a placebo (a substance with no active ingredient). Non-smokers without severe hearing loss and not dependent on drugs or prescription medications might be suitable candidates. As an Early Phase 1 trial, this research aims to understand how nicotine gum affects hearing and brain activity, offering participants a chance to contribute to groundbreaking science.

Do I have to stop taking my current medications?

Yes, you must 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 often helps people quit smoking. Many have used it, providing extensive knowledge about its safety. However, like any treatment, it can cause side effects. Some report a bad taste, nausea, or an upset stomach. Others may experience mouth irritation, known as stomatitis.

While nicotine can be harmful in large amounts, using it in gum form is generally safer than smoking. This study uses a 6 mg dose, similar to those commonly used for smoking cessation. This suggests that the safety of nicotine gum in this study is likely comparable to its use for quitting smoking.

Overall, while nicotine gum is usually well-tolerated, awareness of these possible side effects is important. Participants should discuss any concerns with the trial team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for age-related hearing deficits?

Researchers are excited about using nicotine gum for hearing improvement because it offers a novel approach by leveraging nicotine's potential neuroprotective effects. Unlike typical hearing treatments that might involve hearing aids or cochlear implants, nicotine gum is easy to administer and non-invasive. It's also intriguing because, instead of focusing on mechanical hearing aids, it aims to enhance neural processing related to hearing, potentially improving auditory function from within the brain. This unique mechanism of action could open up new possibilities for addressing age-related hearing issues.

What evidence suggests that nicotine gum might be an effective treatment for age-related hearing improvement?

Research shows that nicotine can help the brain process sounds more effectively. It enhances the ability to hear important sounds in noisy environments and focus on them. Nicotine activates certain brain cells related to hearing, which tend to decline with age. Studies have found that nicotine filters out unnecessary sounds, allowing concentration on what’s important. This trial will compare nicotine gum with placebo gum to evaluate whether nicotine gum might help older adults improve their hearing by boosting brain functions related to hearing. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael A Silver, PhD

Principal Investigator

University of California, Berkeley

Are You a Good Fit for This Trial?

This trial is for aging adults who are non-smokers or very light smokers, as indicated by a low score on the Fagerström index. Participants should not have significant hearing loss, regular prescription medication use (except oral contraceptives), drug dependency, smoking habits above a minimal level, or a history of serious psychiatric, neurological conditions, diabetes, kidney failure or heart disease.

Inclusion Criteria

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

Exclusion Criteria

History of psychiatric illness

I have had kidney failure in the past.

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 before fMRI measurements to assess auditory-cognitive function

1 day

1 visit (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 whether nicotine gum can improve auditory function in older adults by enhancing their ability to focus on sounds amidst noise. It compares the effects of nicotine gum to placebo gum using fMRI scans to observe changes in how the brain's auditory cortex responds to different sound frequencies.

How Is the Trial Designed?

Group I: Young (18-28 years) participants - nicotine gum Experimental Treatment 1 Intervention

6 mg nicotine gum, one time before fMRI measurements

Group II: Old (60-85 years) participants - nicotine gum Experimental Treatment 1 Intervention

6 mg nicotine gum, one time before fMRI measurements

Group III: Young (18-28 years) participants - placebo gum Placebo Group 1 Intervention

placebo gum, one time before fMRI measurements

Group IV: Old (60-85 years) participants - placebo gum Placebo Group 1 Intervention

placebo gum, one time before fMRI measurements

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, Berkeley

Lead Sponsor

Trials

193

Recruited

716,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study of 314 daily smokers, starting nicotine polacrilex gum treatment 4 weeks before the quit date did not significantly improve smoking abstinence rates compared to starting on the quit date.

Both groups showed similar self-reported and biochemically verified abstinence rates after 12 months, indicating that the timing of nicotine gum initiation may not impact long-term quitting success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine gum treatment before smoking cessation: a randomized trial. Etter, JF., Huguelet, P., Perneger, TV., et al.[2018]

Nicotine replacement therapies, such as nicotine polacrilex and transdermal patches, are generally safe with very rare major adverse effects, making them a viable option for smoking cessation.

These therapies can double long-term abstinence rates, particularly benefiting highly dependent smokers, and produce lower nicotine levels than cigarettes without harmful tar and carbon monoxide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk-benefit assessment of nicotine preparations in smoking cessation. Hughes, JR.[2020]

In a study involving 5,887 adult smokers with early COPD, the use of nicotine polacrilex (NP) was found to be safe, with no significant association between NP use and increased rates of cardiovascular conditions or deaths over 5 years.

While about 25% of NP users reported minor and transient side effects, such as headache and mouth irritation, intensive instruction and monitoring during the smoking cessation program were linked to lower rates of these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of nicotine polacrilex gum used by 3,094 participants in the Lung Health Study. Lung Health Study Research Group. Murray, RP., Bailey, WC., Daniels, K., et al.[2019]

Nicotine gum, which binds nicotine to a polacrilex, is an effective method for treating tobacco dependence by transferring nicotine dependence from cigarettes to a safer form, reducing the risk of relapse.

The effectiveness of nicotine gum can be influenced by factors such as the dose, dosing schedule, and how vigorously it is chewed, highlighting the importance of proper administration for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiologic effects of nicotine polacrilex. Nemeth-Coslett, R.[2019]

The nicotine nasal spray (Nicotrol NS) produced significant hemodynamic changes, such as a notable increase in systolic blood pressure shortly after administration, indicating its rapid absorption and potential effectiveness compared to other forms of nicotine replacement therapy.

Despite the hemodynamic changes, pulmonary function remained unaffected by a single dose of nicotine, suggesting that while the nasal spray impacts cardiovascular parameters, it does not impair respiratory function in healthy nonsmokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and pharmacodynamic effects of nicotine nasal spray devices on cardiovascular and pulmonary function. Fishbein, L., O'Brien, P., Hutson, A., et al.[2015]

In a clinical trial with 1818 smokers, the nicotine polacrilex lozenge demonstrated significant efficacy for smoking cessation, achieving 28-day abstinence rates of 46.0% for the 2-mg dose and 48.7% for the 4-mg dose compared to much lower rates in placebo groups.

The lozenge not only helped smokers quit but also reduced cravings and withdrawal symptoms, with most side effects being moderate and similar to those experienced with nicotine gum, indicating it is a safe option for both low- and high-dependence smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a nicotine lozenge for smoking cessation. Shiffman, S., Dresler, CM., Hajek, P., et al.[2022]

In a 5-year study involving 3923 ex-smokers, those using 2 mg nicotine polacrilex gum (NG) had salivary cotinine levels similar to current smokers, indicating significant nicotine replacement over the long term.

Despite NG users achieving cotinine levels comparable to smokers, the exact mechanism behind this nicotine replacement remains unclear, suggesting further research is needed to understand how NG affects nicotine metabolism in ex-smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levels of cotinine associated with long-term ad-libitum nicotine polacrilex use in a clinical trial. Murray, RP., Nides, MA., Istvan, JA., et al.[2019]

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. 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.

3. 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.

4. clinicaltrial.be clinicaltrial.be/en/details/41482?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Using Nicotine to Reverse Age-related Auditory Processing... For each of the two sessions, the participant will be administered gum before the test. For one of these sessions, the gum will be polacrilex ...

5. 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.

6. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9MAJOR_NICOTINE_GUM_4MG_110BX.pdf

SAFETY DATA SHEET In therapeutic use this product has caused bad taste, nausea, dyspepsia, and stomatitis. This product contains nicotine, which is highly toxic ...

7. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5c67aba-a3c2-4253-b714-dff21e007eeb

Label: NICOTINE- nicotine polacrilex gum, chewing Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child ...

8. 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.

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/anda/2011/076775Orig1s018.pdf

Nicotine Polacrilex Gum USP, 2 mg - accessdata.fda.gov Near the end of a treatment course for smoking cessation, a consumer may only need. 3 to 6 pieces of gum per day (one piece every 4 to 8 hours).

10. 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.