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

Официальное название

Cue-Exposure Response Evaluation: Brain Reactivity to ONPs

Обзор

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.

Подробное описание

This study will evaluate the acute effects of oral nicotine pouch (ONP) use on subjective cigarette craving and prefrontal neural responses to smoking-related cues among adult cigarette smokers. Although oral nicotine pouches do not involve combustion or inhalation, their effects on craving relief and neural cue reactivity following nicotine abstinence remain poorly understood. Characterizing these acute responses may improve understanding of the potential role of oral nicotine pouches as lower-risk nicotine products.

This is a single-arm, within-subject, repeated-measures study consisting of one baseline screening visit and one experimental visit. During the baseline visit, informed consent will be obtained, eligibility will be confirmed, demographic and tobacco use information will be collected, nicotine dependence will be assessed, and head circumference will be measured to determine appropriate functional near-infrared spectroscopy (fNIRS) cap sizing. Participants will also receive instructions to abstain from nicotine use for at least 12 hours before the experimental visit.

At the experimental visit, overnight nicotine abstinence will be verified before participants complete baseline assessments of subjective craving and nicotine withdrawal. Participants will then complete a standardized smoking cue reactivity task while prefrontal brain activity is recorded using functional near-infrared spectroscopy (fNIRS). Following completion of the baseline task, participants will self-administer one commercially available 6 mg oral nicotine pouch and complete a standardized 25-minute absorption period. Participants will then complete an identical post-pouch cue reactivity task with simultaneous fNIRS recording, followed by post-session assessments of craving, withdrawal, subjective product effects, and product perceptions.

The smoking cue reactivity task consists of repeated presentations of smoking-related and neutral visual cues, followed by guided imagery in which participants imagine smoking a cigarette or performing a comparable neutral behavior while holding the corresponding object. The task is administered before and after nicotine pouch administration using identical procedures to permit within-subject comparisons of neural and subjective responses.

Functional near-infrared spectroscopy is a non-invasive neuroimaging technique that measures changes in oxygenated and deoxygenated hemoglobin within cortical tissue as an indirect measure of neural activity. Brain activity will be recorded continuously throughout both cue reactivity task runs using a standardized prefrontal optode montage. Participants will be monitored throughout study procedures for discomfort, and study procedures will be discontinued if requested by the participant or if study staff determine continuation is not appropriate.

Вмешательства

• Другое Oral 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.
• Поведенческое Smoking 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.

Первичные конечные точки

• Change in Prefrontal Neural Cue Reactivity to Smoking-Related Cues Measured by Functional Near-Infrared Spectroscopy (fNIRS) [Срок оценки: Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session.]
• Change in Subjective Cigarette Craving Measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief) [Срок оценки: Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of Southern California - 3641 Watt Way (HNB B22) — Los Angeles

Публикации

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• Leventhal AM, Waters AJ, Boyd S, Moolchan ET, Lerman C, Pickworth WB. Gender differences in acute tobacco withdrawal: effects on subjective, cognitive, and physiological measures. Exp Clin Psychopharmacol. 2007 Feb;15(1):21-36. doi: 10.1037/1064-1297.15.1.21. PMID 17295582
• Leventhal A, Cho J, Barrington-Trimis J, Pang R, Schiff S, Kirkpatrick M. Sensory attributes of e-cigarette flavours and nicotine as mediators of interproduct differences in appeal among young adults. Tob Control. 2020 Nov;29(6):679-686. doi: 10.1136/tobaccocontrol-2019-055172. Epub 2019 Dec 18. PMID 31852818
• Hughes JR, Hatsukami D. Signs and symptoms of tobacco withdrawal. Arch Gen Psychiatry. 1986 Mar;43(3):289-94. doi: 10.1001/archpsyc.1986.01800030107013. PMID 3954551
• Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x. PMID 1932883
• Rest EC, Brikmanis KN, Mermelstein RJ. Preferred flavors and tobacco use patterns in adult dual users of cigarettes and ENDS. Addict Behav. 2022 Feb;125:107168. doi: 10.1016/j.addbeh.2021.107168. Epub 2021 Oct 30. PMID 34772504
• Pang RD, Goldenson NI, Kirkpatrick M, Barrington-Trimis JL, Cho J, Leventhal AM. Sex differences in the appeal of flavored e-cigarettes among young adult e-cigarette users. Psychol Addict Behav. 2020 Mar;34(2):303-307. doi: 10.1037/adb0000548. Epub 2020 Jan 20. PMID 31961168
• Kroczek AM, Haeussinger FB, Fallgatter AJ, Batra A, Ehlis AC. Prefrontal functional connectivity measured with near-infrared spectroscopy during smoking cue exposure. Addict Biol. 2017 Mar;22(2):513-522. doi: 10.1111/adb.12344. Epub 2015 Dec 21. PMID 26687485

Идентификаторы

NCT: NCT07698470 · UP-25-00525

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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