Recruiting

Nicotine

Sponsor:

UCLA

Code:

NCT04971954

Conditions

Auditory Perceptual Impairment

Aging

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Nicotine gum

Placebo gum

Study Details

Brief 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.

Conditions

Auditory Perceptual Impairment

Aging

Study ID

NCT04971954

Start date

Feb 1, 2022

Status verified date

Aug, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Nicotine gum

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

placebo comparator: Placebo gum

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

Interventions

Nicotine gum

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.

Primary outcome measure

  • Hearing thresholds [ Time Frame: 1 hour ]
  • Modulation detection [ Time Frame: 1 hour ]
  • Envelope following responses [ Time Frame: 2 hours ]

Central Contacts and Locations

Central contacts

Fan-Gang Zeng

9498249107fzeng@uci.edu

Locations

Hearing and Speech Lab

Recruiting

Irvine, California, United States, 92697

Contacts

Fan-Gang Zeng

9498249107fzeng@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • nicotine
  • biomarker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-08-10.