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Acute Nicotine Gum and Tinnitus Loudness in Non-Smoking Adults

NCT07772089 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-08-19

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Xianhui Wang

    lead OTHER

Principal Investigators

  • Xianhui Wang · San Diego State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-25
Primary Completion
2026-08-03
Completion
2026-08-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07772089 on ClinicalTrials.gov