Using Nicotine to Reverse Age-related Auditory Processing Deficits
Nicotine
2 other identifiers
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2021
CompletedFirst Posted
Study publicly available on registry
July 22, 2021
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
March 27, 2026
March 1, 2026
4.4 years
June 16, 2021
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Hearing thresholds
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.
1 hour
Modulation detection
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)).
1 hour
Envelope following responses
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.
2 hours
Secondary Outcomes (3)
Heart rate
10 minutes
Mood change
10 minutes
Nicotine side effects
10 minutes
Other Outcomes (1)
Cognition
1 hour
Study Arms (2)
Nicotine gum
EXPERIMENTALNicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication
Placebo gum
PLACEBO COMPARATORThe placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hearing and Speech Lab
Irvine, California, 92697, United States
Related Publications (3)
Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
PMID: 1932883BACKGROUNDMorris JC, Heyman A, Mohs RC, Hughes JP, van Belle G, Fillenbaum G, Mellits ED, Clark C. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989 Sep;39(9):1159-65. doi: 10.1212/wnl.39.9.1159.
PMID: 2771064BACKGROUNDPham CQ, Kapolowicz MR, Metherate R, Zeng FG. Nicotine enhances auditory processing in healthy and normal-hearing young adult nonsmokers. Psychopharmacology (Berl). 2020 Mar;237(3):833-840. doi: 10.1007/s00213-019-05421-x. Epub 2019 Dec 12.
PMID: 31832719RESULT
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fan-Gang Zeng, PhD
University of California, Irvine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 16, 2021
First Posted
July 22, 2021
Study Start
February 1, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share