Clinical trial NCT04971954: Using Nicotine to Reverse Age-related Auditory Processing Deficits
Official title: Using Nicotine to Reverse Age-related Auditory Processing Deficits: Human Psychophysics and Electrophysiology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Auditory Perceptual Impairment
Aging
Keywords: nicotine
biomarker
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-07-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The nicotine and placebo gums will be administered in randomized, double-blind, counterbalanced fashion.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hearing thresholds
timeFrame: 1 hour
measure: Modulation detection
timeFrame: 1 hour
measure: Envelope following responses
timeFrame: 2 hours
Secondary outcomes:
measure: Heart rate
timeFrame: 10 minutes
measure: Mood change
timeFrame: 10 minutes
measure: Nicotine side effects
timeFrame: 10 minutes
Other outcomes:
measure: Cognition
timeFrame: 1 hour
Locations:
city: Irvine
country: United States
facility: Hearing and Speech Lab
state: California
Study officials:
affiliation: University of California, Irvine
name: Fan-Gang Zeng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pham 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.
citation: 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.
citation: Morris 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.