What this study is
This study tests whether a single dose of nicotine gum changes brain responses to sounds and the ability to detect target sounds in non-smoking adults with chronic tinnitus. In a double-blind, placebo-controlled, within-subject crossover design, each participant attends two sessions and receives a single 4 mg dose of nicotine polacrilex gum at one session and a flavor-matched placebo gum at the other, in random order. After gum administration, EEG is recorded at rest and during an active auditory oddball task. The primary measures are the P3 brain response (amplitude and latency) and oddball task accuracy and reaction time.
What's being tested
- Nicotine polacrilex gum 4 mg
Intervention · DRUG
A single 4 mg dose (one 4 mg piece) of mint nicotine polacrilex gum, chewed continuously for 20 minutes at one chew per second with saliva retained.
- Placebo gum
Intervention · OTHER
Flavor-matched sugar-free mint gum (Trident) matched to the nicotine gum in shape, flavor, color, and texture, chewed under the identical protocol.
Study details
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Within-Subject Crossover Trial of a Single 4 mg Dose of Nicotine Polacrilex Gum on Auditory Oddball P3, Oddball Task Performance, and Resting-State EEG in Non-Smoking Adults With Chronic Tinnitus
- Sponsor
- San Diego State University
- Conditions
- Tinnitus · Chronic Subjective Tinnitus
- Enrolling
- 20 people
- Starts
- 2026-11-01
- Est. completion
- 2027-05-31
- Design
- Double-blind, randomized, crossover, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Non-smoking adult, defined as fewer than 100 cigarettes in a lifetime and none in the past year, with a Fagerstrom Test for Nicotine Dependence score of 2 or less and a negative urinary cotinine test
- Chronic subjective tinnitus of at least 6 months' duration
You can't join if
- Current or recent tobacco or nicotine use
- Pregnancy or breastfeeding
- Unstable cardiovascular disease
- Any condition precluding the psychoacoustic tasks
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openSan Diego State University
San Diego, California, United States
Study team
Sponsor
San Diego State University
Study ID IRB-25-0430-EEG
Principal investigator
Xianhui Wang
San Diego State University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.