Brain/Craving Response to Smoking Cues After Oral Nicotine Pouch Use (NCT07698470) | Clinical Trial Compass
RecruitingNot Applicable
Brain/Craving Response to Smoking Cues After Oral Nicotine Pouch Use
United States45 participantsStarted 2026-04-30
Plain-language 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.
Who can participate
Age range
21 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Prefrontal Neural Cue Reactivity to Smoking-Related Cues Measured by Functional Near-Infrared Spectroscopy (fNIRS)
Timeframe: Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session.
2
Change in Subjective Cigarette Craving Measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief)
Timeframe: Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session.