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Идёт набор NCT07167225

Carcinogen and Toxicant Exposure Among Young Adults Who Co-Use E-cigarettes and Cannabis (Co-Tox Study)

Наблюдательное Cigarette Smoking-Related Carcinoma E-Cig Use

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: Effectiveness of different recruitment approaches, Choice of study completion locations, Cannabis Engagement Assessment, E-cigarette dependence Scale.
Кому может быть актуально
Состояния в реестре: Cigarette Smoking-Related Carcinoma, E-Cig Use. Базовые параметры: 18 лет — 25 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 →

Обзор

This study evaluates the amount of nicotine, cannabis, and toxicants linked to the use of nicotine e-cigarette and/or cannabis products in the blood and urine of young adult users as well as the cannabis and nicotine use behaviors of consumers.

Подробное описание

PRIMARY OBJECTIVE:

I. To evaluate differences in self-reported nicotine and cannabis use behaviors and biomarkers of exposure to toxicants and carcinogens by product use status, to generate effect sizes required to calculate sample sizes needed for a larger study.

Вмешательства

  • Другое Effectiveness of different recruitment approaches
    Subjects will asked which type of recruitment material they've seen when completing the screening survey
  • Другое Choice of study completion locations
    subjects will choose location when coordinator calls to schedule appointment
  • Другое Cannabis Engagement Assessment
    Self reported measure of current cannabis use that contains 30 questions assessing quantity, frequency of use and method of consumption in the past 30 days.
  • Другое E-cigarette dependence Scale
    A 22-item questionnaire measuring e-cigarette dependence. Higher scores indicate greater dependence.

Первичные конечные точки

  • Differences in biomarker levels across groups [Срок оценки: 1 study session lasting 1 hour]
Вторичные конечные точки (6)
  • Differences in self reported nicotine and cannabis use behaviors [Срок оценки: 1 study session (1 hour)]
  • Differences in psychosocial characteristics by group [Срок оценки: 1 study session (1 hour)]
  • Study interest [Срок оценки: Up to 1 year]
  • Recall of study recruitment advertisement type [Срок оценки: 1 study session (1 hour)]
  • Recall of recruitment channel [Срок оценки: 1 study session (1 hour)]
  • Completion method chosen by participants [Срок оценки: 1 study session (1 hour)]

Критерии участия

Критерии включения

  • Young adult (18-25 years old).
  • Ability to read and write in English.
  • Participants must fall into one of the following groups (based on self-report):
  • Predominant e-cigarette consumer: defined as using nicotine-containing e-cigarettes daily for the past six months but not having used other nicotine containing products more than weekly or cannabis products for the past month.
  • Predominant cannabis consumer: defined as using cannabis at least 3x/week for the past six months in any form, including smoking, vaping, and oral use, with no more than weekly use of any nicotine or tobacco products.
  • E-cigarette-cannabis co-consumers: defined as daily use of nicotine e-cigarettes and use of cannabis at least 3x/week, including smoking, vaping, and oral use, for at least the past six months, with no use of other nicotine containing products more than weekly.
  • No self-reported diagnosis of kidney disease (current, or within the past year prior to the study visit).
  • Participants must understand the voluntary nature of this study and sign a written informed consent form before proceeding with study activities.

Критерии исключения

  • Individuals under the age of 18 or over the age of 25.
  • Currently pregnant or breastfeeding (female participants).
  • Unwilling or unable to follow protocol requirements

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 1 центр
  • Roswell Park Comprehensive Cancer Center — Buffalo

Идентификаторы

NCT: NCT07167225 · I-4235024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗