Using Nicotine to Reverse Age-related Auditory Processing Deficits

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2026-06-30

Brief Summary

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The present study will evaluate the effects of both aging and nicotine on psychophysical tasks and electrophysiological measures. Nicotine will be administered to study participants in the form of gum that is available as an over-the-counter medication. The hypothesis is that nicotine will reverse the detrimental effects of aging on auditory processing. The proposed experiments will characterize the effects of nicotine and may eventually lead to improved treatments of hearing loss in a variety of patient populations and in healthy aging.

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Detailed Description

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Study participants will be recruited in two age groups: young (18-28 years) and old (60-85). Each participant will participate in two psychophysical and electrophysiological test sessions. 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 that contains 6-mg nicotine, and for the other session, the gum will be a placebo control. The study will be double-blind, meaning that neither the experimenter nor the participant will know whether the participant has received nicotine or placebo for a given session. The study has a cross-over design, meaning that all participants will receive both nicotine and placebo in separate sessions. Finally, the order of drug administration will be counterbalanced, meaning that equal numbers of participants will receive 1) nicotine in session one and placebo in session two, and 2) placebo in session one and nicotine in session two.

Conditions

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Auditory Perceptual Impairment Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The nicotine and placebo gums will be administered in randomized, double-blind, counterbalanced fashion.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication. The placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture.

Study Groups

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Nicotine gum

Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication

Group Type EXPERIMENTAL

Nicotine gum

Intervention Type OTHER

Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication

Placebo gum

The placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture.

Group Type PLACEBO_COMPARATOR

Placebo gum

Intervention Type OTHER

The placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture.

Interventions

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Nicotine gum

Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication

Intervention Type OTHER

Placebo gum

The placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* between 18 and 85 years of age
* non-smokers with a score of 0-2 out of 10 maximum on the Fagerström index of smoking dependency
* cognitive performance within two standard deviations of the CERAD mean

Exclusion Criteria

* less than 18 or greater than 85 years of age
* deafness or excessive hearing loss
* smokers with a score between 3 and 10 on the Fagerström index of smoking dependency
* history of psychiatric illness, neurological disorders, diabetes mellitus, renal failure, or cardiovascular disease
* regular use of prescription medications (excluding oral contraceptives)
* drug dependency

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes