Do a single nicotine pouch affect cigarette craving and brain response to smoking cues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, within-subject study that examines the acute effects of an oral nicotine pouch on cigarette craving and prefrontal neural activity in response to smoking cues. After overnight nicotine abstinence, participants complete baseline craving assessments and a brain-imaging task using fNIRS while viewing smoking-related cues, then receive a 6 mg oral nicotine pouch and repeat the task. The study uses a baseline and experimental visit design with strict abstinence verification and a standardized cue-reactivity protocol. Enrollment targets adults aged 21-55 who smoke regularly and meet moderate-to-high nicotine dependence criteria. Primary outcomes focus on changes in self-reported craving and neural cue reactivity following pouch use.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• University of Southern California - 3641 Watt Way (HNB B22)
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Natalia Peraza — University of Southern California
• Study coordinator: USC Nicotine and Tobacco Studies
• Email: USCONPStudy@gmail.com
• Phone: 213-821-0807

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.