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Идёт набор NCT06909500

A Digital Intervention (ACT on Vaping App) for Vaping Cessation in Young Adult E-Cigarette Users

Без фазы С лечением Nicotine Dependence Tobacco-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: Smartphone app, Smartphone app, Text Message, Text Message.
Кому может быть актуально
Состояния в реестре: Nicotine Dependence, Tobacco-Related Carcinoma. Базовые параметры: 18 лет — 30 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
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Официальное название

ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation

Обзор

This clinical trial evaluates a smartphone application (app) called Acceptance and Commitment Therapy (ACT) on Vaping for helping young adults quit using electronic cigarettes (e-cigarettes). E-cigarettes pose numerous risks, particularly to youth and young adults. Addressing the high prevalence of e-cigarette use by young adults requires effective and accessible treatments to support current users to quit. Research shows this group prefers and benefits from newer methods of treatment delivery such as digital interventions. ACT on Vaping is a digital therapeutic intended to deliver behavioral therapy to young adults who vape to motivate and support abstinence from all nicotine and tobacco products. The app contains sessions that promote awareness of cues that trigger tobacco use and teach skills for responding to these triggers in a way that is tailored for the participant's readiness to quit. Receiving access to the ACT on Vaping app may be effective in helping young adults quit vaping.

Подробное описание

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants use the ACT on Vaping app (Version A) and receive a text messaging program to motivate and support quitting. Participants also receive incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess their vaping status.

ARM II: Participants use the ACT on Vaping app (Version B) and receive incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess their vaping status.

After completion of study intervention, participants are followed up at 3, 5.5, and 6 months.

Вмешательства

  • Поведенческое Smartphone app
    Receive access to the ACT on Vaping app
  • Поведенческое Smartphone app
    Receive access to the ACT on Vaping app
  • Другое Text Message
    Receive incentivized text messages to access vaping status
  • Другое Text Message
    Receive intervention text messages
  • Другое Survey Administration
    Ancillary studies

Первичные конечные точки

  • Cotinine-confirmed 30-day point prevalence abstinence from all nicotine and tobacco [Срок оценки: At 6 months post-randomization]
Вторичные конечные точки (5)
  • Self-reported 30-day point prevalence abstinence from vaping [Срок оценки: At 3 months post-randomization]
  • Self-reported 30-day point prevalence abstinence from vaping [Срок оценки: At 6 months post-randomization]
  • Cotinine-confirmed 7-day point prevalence abstinence from all nicotine and tobacco [Срок оценки: At 3 months post-randomization]
  • Number of 24-hour quit attempts [Срок оценки: Baseline to 3 months post-randomization]
  • Change in readiness to quit using electronic cigarettes (e-cigarettes) on the Contemplation Ladder [Срок оценки: Baseline to 3 months post-randomization]

Критерии участия

Критерии включения

  • Age 18-30
  • Current weekly user of e-cigarette product(s) for the last 30 days
  • Has a smartphone; either an Android (running version 12 or higher) or iPhone (running iOS version 17 or higher, iPhone 11 or more recent)
  • Experience downloading and using one or more apps on their smartphone
  • Have a mobile data plan and/or access to WiFi to support the use of the ACT on Vaping app
  • Has access to text messaging
  • Has an email address
  • United States (US) resident, with a US mailing address
  • Willing to complete all study procedures
  • Comfortable reading and writing in English

Критерии исключения

  • Currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (note: use of these treatment is allowable during trial participation)
  • Member of the same household as another research participant
  • Currently in prison
  • Google voice number as sole phone number, due to its association with fraudulent study entry attempts
  • Is ineligible per fraud prevention protocol
  • Employees/family of investigator or study center

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
Двойное слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Fred Hutch/University of Washington Cancer Consortium — Seattle

Идентификаторы

NCT: NCT06909500 · RG1125194 · NCI-2025-01611 · UH3DA057032

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗