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NCT Number: NCT04971954

Using Nicotine to Reverse Age-related Auditory Processing Deficits

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hearing and Speech Lab

Irvine, California, 92697, United States

Location status: Recruiting

Location contact

Fan-Gang Zeng

CONTACT

[email protected]

9498249107

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine gum

Other

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

Placebo gum

Other

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

Primary outcomes

  1. Hearing thresholds

    Time frame: 1 hour

    Hearing thresholds in dB SPL will be measured as a function of sound frequency from 125 Hz to 8000 Hz in quiet or in noise.

  2. Modulation detection

    Time frame: 1 hour

    Amplitude-modulated sounds will be presented at 70 dB SPL or a comfortable level. The detection threshold in percent modulation depth (m= 0 to 100) will be recorded and converted into signal-to-noise ratios in dB (=20log(m)).

  3. Envelope following responses

    Time frame: 2 hours

    Electrophysiological responses will be recorded in response to amplitude or frequency-modulated sounds. The sounds will be presented at 70 dB SPL or a comfortable level. The EEG signal strength that is in synchrony with the modulation frequency in micro-Volts will be recorded.

Secondary outcomes

  1. Heart rate

    Time frame: 10 minutes

    Pulse rate in pulses per minute will be measured via pulse oximetry.

  2. Mood change

    Time frame: 10 minutes

    Mood change will be measured by a 9-category rating scale including: energy, contentedness, focus, relaxation, calmness, alertness, hunger etc.

  3. Nicotine side effects

    Time frame: 10 minutes

    Side effects will be rated on a 5-point scale including: 1 = none (no symptoms at all); 2 = mild (slight jitters); 3 = moderate (jittery, slight dull headache); 4 = moderately severe (jittery, dull headache, mild nausea); 5 = severe (jittery, dull or pounding headache, nausea, vomiting).

Other outcomes

  1. Cognition

    Time frame: 1 hour

    Word learning, recall and animal fluency tests from the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) will be measured and normalized to the national standard distribution, with a score of 0 equaling to the mean and 1 being one standard deviation above the mean performance.

Study contacts

Contact information is provided by the study sponsor or research team.

Fan-Gang Zeng

CONTACT

[email protected]

9498249107

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: Nicotine

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2021
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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