Oral Nicotine Pouch Use and Brain Response to Smoking Cues

This study is looking at how a single 6 mg oral nicotine pouch affects cigarette cravings and brain activity in people who smoke. Researchers want to see if using an oral nicotine pouch can reduce your craving for cigarettes and change how your brain reacts to smoking-related sights and thoughts. You might be able to join if you are between 21 and 55 years old, smoke cigarettes regularly, and are willing to try an oral nicotine pouch. The study will measure changes in your brain's response to smoking cues using a special brain scan (fNIRS) and your craving levels before and after using the pouch. The study is currently unclear on its recruitment status and plans to include 45 participants.

Study design
This is a single-arm study, meaning all participants will receive the same intervention. It involves a small group of 45 participants.
What's involved
You will have one screening visit and one experimental visit. For the experimental visit, you will need to not use nicotine for at least 12 hours beforehand.
Compensation
Not stated in the trial record.
Follow-up
Your brain activity and craving levels will be measured at baseline and about 25 minutes after using the oral nicotine pouch during the experimental session.

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NCT07698470

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

Recruiting
NAAges 21–55InterventionalBasic science
University of Southern California
~45 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Oral Nicotine PouchSmoking Cue Reactivity Task

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Prefrontal Neural Cue Reactivity to Smoking-Related Cues Measured by Functional Near-Infrared Spectroscopy (fNIRS)
Measured over Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session.
+1 more outcome measured
Nicotine Dependence
1 sites across 1 states
California1
  • Natalia Peraza · PRINCIPAL_INVESTIGATOR · University of Southern California
  • John Monterosso · STUDY_CHAIR · University of Southern California

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Eligibility criteria

Inclusion

Age 21 years - 55 years
Self-reported use of cigarettes within the past 30 days
Biochemical confirmation of cigarette use:
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

Age younger than 21 years or older than 55 years
Biochemical evidence inconsistent with recent cigarette use:
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
  • Change in Prefrontal Neural Cue Reactivity to Smoking-Related Cues Measured by Functional Near-Infrared Spectroscopy (fNIRS)Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session.

    Prefrontal neural responses to smoking-related and neutral cues will be assessed using functional near-infrared spectroscopy (fNIRS). The primary outcome will be the within-subject change in oxygenated (HbO) and deoxygenated (HbR) hemoglobin concentration from the pre-pouch assessment to the post-pouch assessment. Larger positive HbO responses to smoking-related cues indicate greater neural cue reactivity.

  • Change in Subjective Cigarette Craving Measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief)Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session.

    Subjective cigarette craving will be assessed using the Questionnaire of Smoking Urges-Brief (QSU-Brief). The QSU-Brief consists of 10 items, each rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). Total scores range from 10 to 70, with higher scores indicating greater cigarette craving (worse outcome). The primary outcome will be the within-subject change in total QSU-Brief score from the pre-pouch assessment to the post-pouch assessment.