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Идёт набор NCT07111234

Studying Flavors and Cooling Agents in Oral Nicotine Pouches to Understand User Preferences

Без фазы С лечением Cigarette Smoking-Related Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Carbon Monoxide Measurement, Nicotine Oral Pouch, Questionnaire Administration, Smoke usual brand cigarette.
Кому может быть актуально
Состояния в реестре: Cigarette Smoking-Related Carcinoma. Базовые параметры: от 21 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Examining the Role of Cooling Agents in Oral Nicotine Pouches

Обзор

This clinical trial studies how the flavors and synthetic coolant properties in oral nicotine pouches (ONPs) compare to one another and how these characteristics are perceived by users. ONPs are placed between the gum and lip, and the nicotine is absorbed in the mouth. They have a strong potential for harm reduction if smokers can switch to using them, and they are growing in popularity. One factor that could be contributing to the increase in popularity is the wide range of flavors, including mint or menthol. With recent flavor restriction policies that have gone into effect in certain areas of the United States, ONPs are now including synthetic cooling agents (WS-3) in place of the flavors. They provide a cooling sensation, but do not have a characterizing flavor, like mint or menthol, allowing them to be sold where flavor restriction policies are in place. Learning more about the flavors and cooling properties in ONPs and user preferences may help researchers guide future ONP regulation and understand how these characteristics may be used as a potential harm reduction or quit smoking tool.

Подробное описание

PRIMARY OBJECTIVES:

I. Evaluate the individual and joint effects of menthol flavors and WS-3 on appeal of ONPs.

II. Test the individual and joint effects of menthol flavors and WS-3 on self-reported relief of withdrawal and craving symptoms associated with use of ONPs.

II. Compare demand for ONPs that vary according to menthol flavors and WS-3.

OUTLINE: Participants are randomized to sample 4 ONPs in a 1 visit, 4-session, randomized cross-over study.

Participants sample four randomly-ordered ONPs with flavors consisting of WS-3 only, menthol only, menthol + WS-3, and no menthol or WS-3 over 10 minutes each, with washout periods of 10 minutes between each ONP use period.

Вмешательства

  • Процедура Carbon Monoxide Measurement
    Ancillary studies
  • Препарат Nicotine Oral Pouch
    Sample randomly-ordered ONPs
  • Другое Questionnaire Administration
    Ancillary studies
  • Препарат Smoke usual brand cigarette
    Participant will smoke their usual brand of cigarette during 1 study visit for 5 minutes.

Первичные конечные точки

  • Appeal ratings [Срок оценки: 5, 15, and 30 minutes after initial product use. To be completed during the cigarette visit.]
  • Sensory ratings [Срок оценки: 5, 15, and 30 minutes after initial product use. To be completed on the day of the study visit. The visit will last approximately 2.5 hours]
  • Withdrawal and Craving [Срок оценки: 0, 5, 15, and 30 minutes after initial product use.To be completed on the day of the study visit. The visit will last approximately 2.5 hours]
  • Demand indices [Срок оценки: At the end of each ONP sampling session. To be completed on the day of the study visit. The visit will last approximately 2.5 hours]

Критерии участия

Критерии включения

  • Age 21 years or older
  • Willing to complete study procedures, including abstaining from all tobacco, nicotine, and marijuana for 12 hours before clinic visits
  • Ability to read and speak English
  • Has smoked >= 100 cigarettes
  • Smokes >= 5 cigarettes/day for past year

Критерии исключения

  • Use other tobacco products (including ONPs) more than 10 days per month
  • Unstable or significant psychiatric conditions (past and stable conditions allowed)
  • Pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test before each visit)
  • History of cardiac event or distress within the past 3 months
  • Currently attempting to quit all tobacco use

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Одна группа
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Ohio State University Comprehensive Cancer Center — Columbus

Идентификаторы

NCT: NCT07111234 · OSU-24236 · NCI-2025-04693

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗