Brain/Craving Response to Smoking Cues After Oral Nicotine Pouch Use
ConditionNicotine Dependence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-55
SponsorUniversity of Southern California
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Age 21 years - 55 years
Self-reported use of cigarettes within the past 30 days
Fagerström Test for Nicotine Dependence (FTND) score ≥5, indicating moderate to high nicotine dependence
Fluent in English
Disqualifiers
Age younger than 21 years or older than 55 years
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)
Trial design
Design model
Single group
Treatments tested in this trial
Oral Nicotine Pouch
Other interventionParticipants 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.
Smoking Cue Reactivity Task
BehavioralParticipants 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.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Acute Oral Nicotine Pouch AdministrationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Prefrontal Neural Cue Reactivity to Smoking-Related Cues Measured by Functional Near-Infrared Spectroscopy (fNIRS)
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.
Time frame
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)
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.
Time frame
Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session.Sponsors and contacts
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Source ClinicalTrials.gov