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Идёт набор NCT06260683

A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior

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: Nicotine Replacement, Questionnaire Administration, Vaping, Vaping.
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

A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-Cigarettes on Smoking Behavior

Обзор

This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) vs. non-tobacco flavored ECs vs. nicotine replacement therapy (patches and lozenges) on smoking behavior in current cigarette smokers. ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use and learn how ECs affect smoking behaviors and health.

Подробное описание

PRIMARY OBJECTIVES:

I. Determine PEC versus vs. TEC vs. nicotine replacement therapy (NRT) on tobacco use patterns including product switching, abstinence from cigarettes, and number of cigarettes smoked.

II. Examine PEC vs. TEC vs. NRT on cigarette craving, withdrawal symptoms, and perceived nicotine dependence.

III. Examine PEC vs. TEC on product appeal and uptake, including initial trial, days used during period of product provision, and purchase and continued use after 12 weeks.

OUTLINE: Participants are randomized to 1 of 3 arms.

ARM I: Participants receive PEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage.

ARM II: Participants receive TEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage.

ARM III: Participants receive NRT (nicotine patches and lozenges) for 14 weeks, including a 2-week pre-switch period to become familiar with usage.

Participants in all arms participate in discussions throughout the trial.

SURVEILLANCE PHASE: Participants in all arms are followed for 12-weeks after completion of study procedures.

Вмешательства

  • Препарат Nicotine Replacement
    Given nicotine patches and nicotine lozenges
  • Другое Questionnaire Administration
    Ancillary studies
  • Устройство Vaping
    Given Preferred Flavor e-liquid
  • Устройство Vaping
    Given Tobacco flavored e-liquid

Первичные конечные точки

  • 7-day point prevalence complete switching rate [Срок оценки: At week 14]
  • Biochemically verified 7-day point prevalence abstinence from cigarettes [Срок оценки: At week 14]
  • Cigarettes smoked per day [Срок оценки: At week 14]
Вторичные конечные точки (7)
  • Change in cigarettes smoked per day [Срок оценки: From baseline to 26 weeks]
  • Change in nicotine dependence [Срок оценки: From baseline to 14 weeks]
  • Changes in cigarette craving and nicotine withdrawal [Срок оценки: At baseline, 2, 6, 14, and 26 weeks]
  • Number of days used in past week [Срок оценки: At 2, 6, and 14 weeks]
  • Number of days used in past month [Срок оценки: At 6 and 14 weeks]
  • Product appeal [Срок оценки: At 2, 6, 14, and 26 weeks]
  • Continued use of ECs [Срок оценки: From 14 to 26 weeks]

Критерии участия

Критерии включения

  • >= 21 years old
  • Smoke >= 5 cigarettes per day for the past year
  • Willing to use either an EC or NRT
  • Read and speak English
  • Have a smartphone

Критерии исключения

  • Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation
  • Current use of an EC > 4 days a month
  • Diagnosed medical conditions of lung disease, asthma, cystic fibrosis, heart disease or chronic obstructive pulmonary disease (COPD)
  • Unmanaged (unmedicated and/or without counseling) diagnosis of schizophrenia
  • History of cardiac event or distress within the past 3 months
  • Currently pregnant, planning to become pregnant within 6 months, or breastfeeding
  • High blood pressure not controlled by medications
  • Serious angina pectoris or chest pain
  • Stroke within the past three months
  • Known allergy to propylene glycol or vegetable glycerin
  • Serious underlying arrhythmias, irregular heartbeat or abnormal heart rhythm
  • Live in same household as another study participant

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

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

Идентификаторы

NCT: NCT06260683 · OSU-22240 · NCI-2023-04102 · R01DA057327

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗