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Набор скоро начнётся NCT07688304

The Abuse Liability of IQOS Heated Tobacco Products Among Adults Who Smoke

Без фазы С лечением Tobacco

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: Smoking Behavioral Research (IQOS), Smoking Behavioral Research (UBC).
Кому может быть актуально
Состояния в реестре: Tobacco. Базовые параметры: 21 лет — 65 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

Studying User Sensory Experiences and Smoking Behavior of IQOS Heated Tobacco Products to Improve Harm Reduction Among Adult Cigarette Smokers

Обзор

This clinical trial aims to evaluate user sensory experiences and smoking behavior when using IQOS heated tobacco products (HTPs) among adults who smoke cigarettes.

Подробное описание

PRIMARY OBJECTIVES:

I. Assess the abuse liability (appeal and sensory effects) of IQOS. II. Examine the puffing topography of IQOS.

SECONDARY OBJECTIVES:

I. Evaluate the impact of flavor on the sensory effects, appeal, and puffing topography of IQOS.

II. Evaluate the effect of perceived harm on IQOS use behavior.

EXPLORATORY OBJECTIVE:

I. Examine acute changes to pulmonary health associated with IQOS use.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants use IQOS HeatSticks (flavor matched to their usual cigarette) as much as desired (ad lib) over 60 minutes during laboratory visit 1. At least forty-eight hours later, participants smoke their usual brand cigarette (UBC) ad lib over 60 minutes during laboratory visit 2.

ARM II: Participants smoke their UBC ad lib over 60 minutes during laboratory visit 1. At least forty-eight hours later, participants use IQOS HeatSticks (flavor matched to their usual cigarette) ad lib over 60 minutes during laboratory visit 2.

Вмешательства

  • Поведенческое Smoking Behavioral Research (IQOS)
    Use IQOS HeatSticks (flavor matched to the participant's usual cigarette)
  • Поведенческое Smoking Behavioral Research (UBC)
    Smoke UBC

Первичные конечные точки

  • Product Appeal [Срок оценки: Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session]
  • Product Sensory Attributes [Срок оценки: Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session]
  • Economic demand breakpoint [Срок оценки: Minute 60 of product use session]
  • Satisfaction and psychological reward [Срок оценки: Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session]
  • Abuse Liability Via Puff Topography - Total Smoking Time [Срок оценки: Minute 60 of product use session]
  • Abuse Liability Via Puff Topography - Average Puff Duration [Срок оценки: Minute 60 of product use session]
  • Abuse Liability Via Puff Topography - Average Flow Rate [Срок оценки: Minute 60 of product use session]
  • Abuse Liability Via Puff Topography - Average Inter-Puff Interval [Срок оценки: Minute 60 of product use session]
  • Abuse Liability Via Puff Topography - Average Puff Volume [Срок оценки: Minute 60 of product use session]
  • Craving/withdrawal [Срок оценки: Minute 0 before product use session, Minute 5 of product use session, Minute 35 of product use session, minute 60 of product use session]
Вторичные конечные точки (5)
  • Spirometry FEV1 [Срок оценки: Minute 0 before start of product use session and minute 60 of product use session]
  • Spirometry FVC [Срок оценки: Minute 0 before start of product use session, Minute 60 of product use session]
  • Spirometry FEV1/FVC [Срок оценки: Minute 0 before start of product use session, Minute 60 of product use session]
  • Used filter count [Срок оценки: Minute 60 of product use session]
  • Harm Perception [Срок оценки: Minute 60 of product use session]

Критерии участия

Критерии включения

  • Adults 21-65 years
  • Adults who smoke (defined as ≥ 5 days weekly use of either menthol or non-menthol cigarettes over the past 3 months)
  • Willing to provide informed consent and abstain from using nicotine products 12 hours before each visit
  • Willing to bring UBC to each study visit
  • Read, write and speak English

Критерии исключения

  • Current use of other non-combustible nicotine products (e.g., electronic \[e\]-cigarettes, HTPs; \[defined as ≥ 5 days weekly use in the past 30 days\])
  • Planning to quit nicotine use and/or use of any smoking cessation medication in the past 30 days
  • Current diagnosis of any lung diseases (e.g., asthma, cystic fibrosis, or chronic obstructive pulmonary disease)
  • Self-reported unstable or significant psychiatric conditions (past/stable conditions will be allowed)
  • History of cardiac event or distress within the past 3 months
  • Deaf, hard of hearing, or have a severe motor disability
  • Are currently pregnant, planning to become pregnant, or breastfeeding (urine pregnancy test will be completed at each visit throughout the study)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Другое

Центры проведения

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

Идентификаторы

NCT: NCT07688304 · OSU-26080 · NCI-2026-04495 · STUDY20260624 · U54CA287392

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗