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Trials / Recruiting

RecruitingNCT04971954

Using Nicotine to Reverse Age-related Auditory Processing Deficits

Using Nicotine to Reverse Age-related Auditory Processing Deficits: Human Psychophysics and Electrophysiology

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
48 (estimated)
Sponsor
University of California, Irvine · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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

Interventions

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

Timeline

Start date
2022-02-01
Primary completion
2026-06-30
Completion
2026-06-30
First posted
2021-07-22
Last updated
2026-03-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04971954. Inclusion in this directory is not an endorsement.