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Nicotinic Acetylcholine Receptor Agonist

Nicotine Gum for Hearing Impairment (Nicotine Trial)

N/A

Recruiting

Led By Fan-Gang Zeng, PhD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18 and 85 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 minutes

Awards & highlights

Nicotine Trial Summary

This trial will study the effects of nicotine and aging on hearing ability. Nicotine will be given in gum form to participants, and it is hypothesized that it will help offset the negative effects of aging on hearing. The results of the trial may help create better treatments for hearing loss.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Nicotine gum may cause side effects such as headaches, hiccups, upset stomach, jaw discomfort from chewing, and possibly increased heart rate. Long-term effects are not well-studied but could include dependence on nicotine.

Nicotine Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 85 years old.

Nicotine Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Envelope following responses

Hearing thresholds

Modulation detection

Secondary outcome measures

Heart rate

Mood change

Nicotine side effects

Other outcome measures

Cognition

Nicotine Trial Design

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor

544 Previous Clinical Trials

1,922,995 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,674 Previous Clinical Trials

28,020,857 Total Patients Enrolled

Fan-Gang Zeng, PhDPrincipal InvestigatorUniversity of California, Irvine

Media Library

Nicotine gum (Nicotinic Acetylcholine Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04971954 — N/A

Hearing Impairment Clinical Trial 2023: Nicotine gum Highlights & Side Effects. Trial Name: NCT04971954 — N/A

Nicotine gum (Nicotinic Acetylcholine Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04971954 — N/A

Frequently Asked Questions

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

How many participants is the maximum capacity for this clinical trial?

"Affirmative, per details hosted on clinicaltrials.gov this medical study is still recruiting patients. The trial was originally posted on February 1st 2022 and most recently modified on the 12th of that same month. In total 48 individuals need to be recruited from one single site."

Answered by AI

Does this clinical investigation permit persons over the age of fifty-five to participate?

"To be considered for this trial, applicants must have an age between 18 and 85 years old. There are 1 clinical trials specifically designed for minors and 238 that focus on elderly patients."

Answered by AI

To whom is this experimental treatment open?

"This study is set to include 48 individuals whose ages range from 18-85. Essential eligibility prerequisites are: age between 18 and 85, a score of 0-2 on the Fagerström index for tobacco addiction, and cognitive performance within two standard deviations of the CERAD mean."

Answered by AI

Are there any available positions for volunteers in this research endeavor?

"The public data hosted on clinicaltrials.gov attests that this medical experiment is currently open to new participants. This trial was initially posted on February 1st, 2022 and most recently updated just a few days ago, 12th of the same month."

Answered by AI