- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02896400
Optimizing Tobacco Dependence Treatment in the Emergency Department
Обзор исследования
Статус
Подробное описание
The investigators propose to optimize the identification and treatment of adult smokers seen in a hospital ED. To do this the Multiple Optimization Strategy (MOST) will be employed to develop a multicomponent intervention that will consist of some combination of the following: (1) a Brief Negotiation Interview (BNI, a variant of a motivational interview), delivered by a trained research assistant; (2) provision of 6 weeks of nicotine patches and gum to the research participant, with application of the first patch in the ED (NRT); (3) active referral to the Connecticut Smokers' Quitline (QL); and (4) enrollment in the SmokefreeText a short-messaging service (SMS) texting program for mobile phones (Text). Using MOST principles, the first phase of the study will use a 2x2x2x2 full-factorial design to identify the components most likely to be efficacious in combination. Although the factorial design requires the allocation of participants to 16 different combinations of the 4 components (Table 1), evaluation of each individual component is performed comparing all of those receiving a component to all of those not receiving a component, making this an efficient design. For instance, evaluation of the BNI component will compare those randomized to arms 1 through 8 to those in arms 9 to 16.The second phase will consist of designing and proposing a 2-arm randomized clinical trial comparing the efficacy of the multicomponent intervention package to usual care; this will be conducted in a future application.
The specific aims of this proposed study are:
Aim 1. To conduct a fully powered factorial randomized trial of 1056 adult smokers to test the efficacy of 4 key components of ED-initiated tobacco treatment: Brief Negotiated Interview (BNI), nicotine replacement therapy (NRT), Quitline referral (QL), and SmokeFreeText (Text).
Aim 2. To identify the most efficacious components of our intervention, within fixed constraints of cost effectiveness and feasibility/acceptability to providers and subjects.
Aim 3. To lay the groundwork for a future randomized trial testing the previously identified components, delivered as a package, against a control arm in a new cohort of adult ED smokers.
Our associated hypotheses are:
- At 3 months, at least 1 intervention component will yield a biochemically verified tobacco abstinence rate at least 5% greater than in the control condition. Carbon monoxide breath test will be used for biochemical verification.
- At 3 months, at least 1 intervention will be cost-effective, using a societal perspective.
- At 3 months, at least 1 intervention will be acceptable and feasible to providers and subjects.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
-
-
Connecticut
-
New Haven, Connecticut, Соединенные Штаты, 06519
- Yale School of Medicine
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- 18 years or older
- have smoked >= 100 cigarettes lifetime
- describe themselves as every or some day smokers
- smoke at least 5 cigarettes/day
- own a cellphone with texting capability
- are able to give written informed consent
Exclusion Criteria:
- Inability to read or understand English
- currently receiving formal tobacco dependence treatment
- life-threatening or unstable medical, surgical, or psychobehavioral condition
- unable to provide at least one collateral contact
- live out-of-state
- leaving the ED against medical advice
- pregnant (self-report or urine testing), nursing, or trying to conceive.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Факторное присвоение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: BNI+NRT+QL+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
|
Brief motivational interview on smoking behavior
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
Экспериментальный: BNI+NRT+QL
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
|
Brief motivational interview on smoking behavior
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
|
Экспериментальный: BNI+NRT+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
|
Brief motivational interview on smoking behavior
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
Экспериментальный: BNI+NRT
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
|
Brief motivational interview on smoking behavior
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
|
Экспериментальный: BNI+QL+Text
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
|
Brief motivational interview on smoking behavior
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
Экспериментальный: BNI+QL
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)
|
Brief motivational interview on smoking behavior
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
|
Экспериментальный: BNI+Text
Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)
|
Brief motivational interview on smoking behavior
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
Экспериментальный: BNI only
Brief Negotiated Interview (BNI)
|
Brief motivational interview on smoking behavior
|
Экспериментальный: NRT+QL+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
|
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
Экспериментальный: NRT+QL
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
|
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
|
Экспериментальный: NRT+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
|
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
Экспериментальный: NRT only
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
|
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
|
Экспериментальный: QL+Text
Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
|
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
Экспериментальный: QL only
Referral to CT Smokers Quitline (QL)
|
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
|
Экспериментальный: Text only
Registration in SmokefreeText (Text)
|
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
Без вмешательства: Control
Control arm, no intervention
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Tobacco Abstinence
Временное ограничение: 3 months
|
Abstinence self reported and verified by exhaled carbon monoxide
|
3 months
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Steven L Bernstein, MD, Yale School of Medicine, Department of Emergency Medicine
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Психические расстройства
- Химически индуцированные расстройства
- Патологические процессы
- Расстройства, связанные с употреблением психоактивных веществ
- Атрибуты болезни
- Чрезвычайные ситуации
- Расстройство, связанное с употреблением табака
- Физиологические эффекты лекарств
- Нейротрансмиттерные агенты
- Молекулярные механизмы фармакологического действия
- Автономные агенты
- Агенты периферической нервной системы
- Холинергические агенты
- Ганглиозные стимуляторы
- Никотиновые агонисты
- Холинергические агонисты
- Никотин
Другие идентификационные номера исследования
- 1603017332
- 1R01CA201873-01A1 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .