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Идёт набор NCT06556238

Metabolism-Informed Care to Aid Alaska Native People to Quit Smoking (QUIT)

Без фазы С лечением Smoking Cessation

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 Metabolite Ratio.
Кому может быть актуально
Состояния в реестре: Smoking Cessation. Базовые параметры: от 18 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

Metabolism-Informed Care to Aid Alaska Native People to Quit Smoking (QUIT): Pilot Intervention and Assessment of Barriers and Facilitators of Implementation

Обзор

The purpose of this study is to refine and pilot an intervention using the Nicotine Metabolite Ratio (NMR) to inform the selection of pharmacologic treatment to increase smoking abstinence among Alaska Native and American Indian people. This is a single-arm pilot trial to assess and improve acceptability and feasibility.

Вмешательства

  • Другое Nicotine Metabolite Ratio
    Blood specimens will be drawn, in clinic, by clinical staff trained in blood collection (e.g., certified medical assistant, nurse). Through regular clinic procedures, lab staff will ship for processing to Quest. Quest uses liquid chromatography tandem mass spectrometry with a limit of detection of 2ng/ml for all analytes and will quantify NMR within 3-6 days of sample arrival. Samples will be consumed during testing. Results of NMR will be returned to primary care providers, and NMR-informed med

Первичные конечные точки

  • Feasibility of intervention implementation: Enrollment [Срок оценки: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks]
  • Feasibility of intervention implementation: Treatment recommendations [Срок оценки: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks]
  • Feasibility of intervention implementation: Semi-structured interviews [Срок оценки: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks]
  • Acceptability of metabolism-informed intervention: Quantitative [Срок оценки: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks]
  • Acceptability of metabolism-informed intervention: Qualitative [Срок оценки: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks]
Вторичные конечные точки (3)
  • Smoking Cessation: Self-report [Срок оценки: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks]
  • Smoking Cessation: Expelled CO [Срок оценки: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks]
  • Smoking Cessation: Nicotine <10ng/mL [Срок оценки: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks]

Критерии участия

Критерии включения

(Patients)

  • Alaska Native or American Indian person by self-report
  • eligible for or already receiving services at Southcentral Foundation (SCF)
  • age 18 years or older
  • daily smoking in the past 30-days
  • if other nicotine or tobacco products are used, cigarettes are main product used
  • planning to schedule an appointment with the Quit Tobacco Program to seek smoking cessation treatment in the next 30 days
  • willing to make a quit attempt within 30 days of enrollment in the Quit Tobacco Program
  • willing to have a blood test to inform their treatment
  • willing to try a pharmacologic treatment
  • willing to provide a saliva sample
  • has phone service
  • has access to broadband internet on mobile phone at home, work, or other location
  • has an Android or iPhone mobile phone compatible with the Smokerlyzer app

(Staff)

\- Staff participants of qualitative interviews to assess acceptability and feasibility of the intervention must be a health care professional at Southcentral Foundation (SCF), involved in the care of one of the participants of the study, that is their care team staff; including but not limited to: primary care providers, tobacco treatment specialists/health educators, pharmacists, nurse case managers, behavioral health consultants, certified medical assistants, and lab technicians.

Критерии исключения

(Patients)

  • Participated in the prior study phase
  • participated in a cessation program during the past 3 months
  • their provider has not approved varenicline in their referral to the Quit Tobacco Program
  • has history of serious hypersensitivity or skin reactions to varenicline
  • has bleeding disorder or is currently receiving cancer treatment
  • questionable capacity or impaired decision-making capacity

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Anchorage Native Primary Care Center — Anchorage

Идентификаторы

NCT: NCT06556238 · 1958237 · S06GM142122

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗