RecruitingNot ApplicableNCT07698470

Brain/Craving Response to Smoking Cues After Oral Nicotine Pouch Use

Cue-Exposure Response Evaluation: Brain Reactivity to ONPs

Sponsor

University of Southern California

Enrollment

45 participants

Start Date

Apr 30, 2026

Study Type

INTERVENTIONAL

Conditions

Nicotine Dependence

Summary

Oral nicotine pouches (ONPs) are non-combustible nicotine products that may reduce cigarette craving and smoking cue-induced brain activity, supporting their potential as harm-reduction tools for adults who smoke cigarettes. This within-subject, repeated-measures study will evaluate the acute effects of a single 6 mg oral nicotine pouch on subjective craving and prefrontal neural responses to smoking-related cues using functional near-infrared spectroscopy (fNIRS). Participants will complete assessments before and after nicotine pouch administration following overnight nicotine abstinence to characterize changes in craving and neural cue reactivity.

Eligibility

Min Age: 21 YearsMax Age: 55 Years

Inclusion Criteria8

Age 21 years - 55 years
Self-reported use of cigarettes within the past 30 days
Biochemical confirmation of cigarette use:
o Carbon monoxide (CO) breath sample ≥10 ppm
Fagerström Test for Nicotine Dependence (FTND) score ≥5, indicating moderate to high nicotine dependence
Fluent in English
Willing to try an oral nicotine pouch
Willing to abstain from nicotine for at least 12 hours prior to each experimental session

Exclusion Criteria7

Age younger than 21 years or older than 55 years
Biochemical evidence inconsistent with recent cigarette use:
o CO breath sample <10 ppm
Expressed intent to reduce or quit nicotine use within the next 30 days
History of medical conditions contraindicated for nicotine use (e.g., uncontrolled hypertension, recent cardiac events)
Primary use of non-cigarette products (e.g., cigars, pipe tobacco, smokeless tobacco)
Prior use of oral nicotine products in their lifetime

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Interventions

OTHEROral Nicotine Pouch

Participants will self-administer one commercially available 6 mg oral nicotine pouch following overnight nicotine abstinence. The pouch will be used for approximately 25 minutes before participants complete the post-pouch cue reactivity assessment.

BEHAVIORALSmoking Cue Reactivity Task

Participants will complete a standardized smoking cue reactivity task before and after oral nicotine pouch administration. During each task, participants will view smoking-related and neutral images, complete guided imagination trials while holding either a cigarette or a neutral object, and undergo simultaneous functional near-infrared spectroscopy (fNIRS) to measure prefrontal brain activity.