Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for 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: cognitive-behavioral withdrawal regulation strategies, relaxation strategies, early withdrawal exposure.
- Кому может быть актуально
- Состояния в реестре: Tobacco Dependence. 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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Обзор
Smoking remains the single most preventable cause of morbidity and mortality in the United States, accounting for approximately half a million deaths every year. The current study will investigate the efficacy and mechanisms of change of a novel smoking cessation intervention. The current study will thus provide essential information regarding a treatment that has the potential to enhance the efficacy of existing smoking cessation interventions, thereby having a beneficial impact on the public health of the United States.
Подробное описание
Cigarette smoking remains the single most preventable cause of mortality and morbidity in the United States. Long-term abstinence rates for even the most rigorous of smoking cessation treatments range between 20% and 35%. It is therefore essential that research continue to investigate novel smoking cessation interventions. Leading contemporary theories of addiction motivation posit that the escape or avoidance of negative affect withdrawal (NAW) symptoms (e.g., anger, anxiety, and depression/sadness) constitutes a strong motivational basis for cigarette smoking and plays a critical role in relapse to cigarette use. However, whereas NAW symptoms appear to exert a powerful influence on smoking cessation treatment outcome, smoking cessation interventions may exert only modest effects on NAW symptoms. Accordingly, it has been proposed that smoking cessation interventions may be augmented by aiding smokers in the practice of NAW regulation strategies. The primary goal of this investigation is to evaluate an early withdrawal exposure plus NAW regulation training intervention for smoking cessation. Specific aims include evaluating the efficacy of the treatment components and investigating potential mediators and moderators of the treatment components. Participants will be adult smokers (N = 400) of at least 5 cigarettes per day with the intention to quit smoking. Using a factorial design, participants will be randomized to early withdrawal exposure (yes vs. no) and behavioral intervention (NAW regulation training vs. relaxation control training), resulting in four distinct conditions. The investigator's primary hypothesis is that early withdrawal exposure plus NAW regulation training will produce higher rates of seven-day point-prevalence abstinence at 1, 3, and 6 months after end-of-treatment, suggesting a synergistic (i.e., non-additive) effect of the two intervention components. Mediators (e.g., in-session withdrawal symptoms) and moderators (e.g., demographic characteristics, tobacco dependence) will be investigated via established analyses. These data will advance the experimental intervention with a focus on targeting mechanisms of change as well as participant characteristics to which the intervention may be tailored. The experimental intervention described in the current proposal has the potential to ultimately enhance the efficacy of existing smoking cessation interventions and will therefore contribute uniquely to the field.
Вмешательства
- Поведенческое cognitive-behavioral withdrawal regulation strategies
Participants will generate and refine individualized withdrawal regulation strategies with the aid of a therapist - Поведенческое relaxation strategies
Participants will generate and refine relaxation techniques with the aid of a therapist - Поведенческое early withdrawal exposure
Exposure to the first 4 hours of abstinence across 4 separate sessions
Первичные конечные точки
- Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence [Срок оценки: 1 month after end-of-treatment]
- Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence [Срок оценки: 3 months after end-of-treatment]
- Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence [Срок оценки: 6 months after end-of-treatment]
Вторичные конечные точки (12)
- Cessation milestones as determined by the Timeline Followback Interview [Срок оценки: 1 month after end-of-treatment]
- Cessation milestones as determined by the Timeline Followback Interview [Срок оценки: 3 months after end-of-treatment]
- Cessation milestones as determined by the Timeline Followback Interview [Срок оценки: 6 months after end-of-treatment]
- Physical tobacco dependence [Срок оценки: 1 month after end-of-treatment]
- Physical tobacco dependence [Срок оценки: 3 months after end-of-treatment]
- Physical tobacco dependence [Срок оценки: 6 months after end-of-treatment]
- Motivational tobacco dependence [Срок оценки: 1 month after end-of-treatment]
- Motivational tobacco dependence [Срок оценки: 3 months after end-of-treatment]
- Motivational tobacco dependence [Срок оценки: 6 months after end-of-treatment]
- Withdrawal symptoms [Срок оценки: 1 month after end-of-treatment]
- Withdrawal symptoms [Срок оценки: 3 months after end-of-treatment]
- Withdrawal symptoms [Срок оценки: 6 months after end-of-treatment]
Критерии участия
Критерии включения
- at least 18 years of age
- smoke at least 5 cigarettes per day
- Expired breath carbon monoxide (CO) reading of at least five parts per million
- report the intention to quit
- reside in the Birmingham area with no plan to relocate outside of the area in the next 6 months
- access to a telephone
Критерии исключения
- inability to speak English
- presence of a condition that contraindicates use of the nicotine patch
- presence of conditions that might interfere with compliance with the protocol or greatly complicate treatment
- any acutely life-threatening disease
- concurrent participation in a formal treatment program for smoking cessation
- current use of any pharmacotherapy for smoking cessation
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Факторный дизайн
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Ryals Public Health Building — Birmingham
Идентификаторы
NCT: NCT03912194 · 000522656 · R01DA045186-01A1