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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
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

Study 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.

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
~2250

Find a Location

Who is running the clinical trial?

University of California, BerkeleyLead Sponsor
176 Previous Clinical Trials
720,447 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,647 Previous Clinical Trials
28,003,646 Total Patients Enrolled
159 Trials studying Aging
75,980 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has recruitment for this experiment been initiated?

"Affirmative. According to details on clinicaltrials.gov, this clinical investigation is in the process of enrolling participants as of today. The trial was initially posted on June 6th 2022 and last modified August 19th 2022; 48 individuals are required at a single medical centre for completion."

Answered by AI

What empirical evidence has been accumulated surrounding the use of Nicotine gum?

"At present, 71 trials are researching Nicotine gum with 5 of those still in Phase 3. Most locations for this research can be found in Green Bay, Wisconsin; however there is a total of 204 sites running these experiements overall."

Answered by AI

Are there any specified criteria to qualify for participation in this research?

"This research project is taking applications from aged 18-85. Interested individuals must not be habitual smokers, as evidenced by a Fagerström index score of 0-2 out of 10."

Answered by AI

What is the cap on total participants for this clinical trial?

"Affirmative. Clinicaltrials.gov documents this medical trial as actively recruiting, having been initially posted on June 6th 2022 and most recently edited August 19th of the same year. At present, 48 participants are needed at a single site to participate in the study."

Answered by AI

Does this investigation accept those who are 75 or older as participants?

"This study welcomes participants between 18 and 85 years old."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~25 spots leftby Dec 2025