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COMPLETED
NCT07772089
PHASE1/PHASE2

Acute Nicotine Gum and Tinnitus Loudness in Non-Smoking Adults

Sponsor: San Diego State University

View on ClinicalTrials.gov

Summary

This study tested whether a single dose of nicotine gum can reduce the loudness of tinnitus (ringing in the ears) in non-smoking adults with chronic tinnitus. Nicotine acts on brain nicotinic acetylcholine receptors that regulate the balance of excitation and inhibition in auditory and attention networks, and may temporarily quiet the phantom sound while improving the ability to focus on relevant sounds. Using a double-blind, placebo-controlled, within-subject crossover design, each participant attended two sessions and received a single 4 mg dose of nicotine polacrilex gum at one session and a flavor-matched placebo gum at the other, in random order. The primary measure was the within-session change in a psychoacoustic match of tinnitus loudness; auditory selective attention was a secondary measure.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Within-Subject Crossover Trial of a Single 4 mg Dose of Nicotine Polacrilex Gum on Psychoacoustic Tinnitus Loudness and Selective Attention in Non-Smoking Adults With Chronic Subjective Tinnitus

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2026-03-25

Completion Date

2026-08-03

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

DRUG

Nicotine polacrilex gum 4 mg

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.

OTHER

Placebo gum

Flavor-matched sugar-free mint gum (Trident) matched to the nicotine gum in shape, flavor, color, and texture, chewed under the identical protocol.

Locations (1)

San Diego State University

San Diego, California, United States