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Nicotinic Acetylcholine Receptor Agonist

Nicotine Gum for Aging-Related Hearing Improvement

Phase < 1
Recruiting
Led By Michael A Silver, PhD
Research Sponsored by University of California, Berkeley
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
History of renal failure
History of neurological disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up functional mri recordings will begin approximately 30 minutes after oral administration of polacrilex or placebo gum and will continue for up to two hours.
Awards & highlights

Summary

This trial will study whether nicotine can help improve hearing in older adults by looking at how the brain responds to sound after nicotine use.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects from nicotine gum may include jaw pain from chewing, headaches, dizziness, hiccups or burping. Nicotine can also cause nausea and might affect heart rate and blood pressure.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had kidney failure in the past.
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I have a history of neurological disorders.
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I am deaf or have significant hearing loss.
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I have diabetes.
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I have a history of heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~functional mri recordings will begin approximately 30 minutes after oral administration of polacrilex or placebo gum and will continue for up to two hours.
This trial's timeline: 3 weeks for screening, Varies for treatment, and functional mri recordings will begin approximately 30 minutes after oral administration of polacrilex or placebo gum and will continue for up to two hours. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
frequency tuning of excitatory auditory fMRI cortical responses
Secondary outcome measures
Auditory Cortex Disorder
amplitude of inhibitory auditory fMRI cortical responses
frequency tuning of inhibitory auditory fMRI cortical responses

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Young (18-28 years) participants - nicotine gumExperimental Treatment1 Intervention
6 mg nicotine gum, one time before fMRI measurements
Group II: Old (60-85 years) participants - nicotine gumExperimental Treatment1 Intervention
6 mg nicotine gum, one time before fMRI measurements
Group III: Young (18-28 years) participants - placebo gumPlacebo Group1 Intervention
placebo gum, one time before fMRI measurements
Group IV: Old (60-85 years) participants - placebo gumPlacebo Group1 Intervention
placebo gum, one time before fMRI measurements
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine gum
2015
Completed Phase 4
~2410

Find a Location

Who is running the clinical trial?

University of California, BerkeleyLead Sponsor
181 Previous Clinical Trials
720,962 Total Patients Enrolled
1 Trials studying Aging
40 Patients Enrolled for Aging
National Institute on Aging (NIA)NIH
1,704 Previous Clinical Trials
28,033,209 Total Patients Enrolled
163 Trials studying Aging
80,063 Patients Enrolled for Aging
Michael A Silver, PhDPrincipal InvestigatorUniversity of California, Berkeley

Media Library

Nicotine gum (Nicotinic Acetylcholine Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05018117 — Phase < 1
Aging Research Study Groups: Young (18-28 years) participants - nicotine gum, Old (60-85 years) participants - nicotine gum, Young (18-28 years) participants - placebo gum, Old (60-85 years) participants - placebo gum
Aging Clinical Trial 2023: Nicotine gum Highlights & Side Effects. Trial Name: NCT05018117 — Phase < 1
Nicotine gum (Nicotinic Acetylcholine Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05018117 — Phase < 1
~19 spots leftby Dec 2025
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