- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01824511
Effects of Quitting Study A Test of Pre-clinical Findings
Does Smoking Cessation Increase Anhedonia? A Test of Pre-clinical Findings
Обзор исследования
Подробное описание
Study design We will recruit until we have 70 current smokers who want to quit at two sites (Univ of Vermont and Dartmouth Medical School). We will also recruit a comparison group of 70 long-time former smokers to assist in interpretation of the results. In the first week, smokers will smoke their usual number of cigs/day. They will then quit and are to remain abstinent for 4 weeks. We will use a schedule of escalating monetary contingencies based on breath and saliva and/or urine samples to encourage abstinence. We will obtain dependent measures twice/week. The primary measures of reward responsivity will be the percent choosing the hard task and the amount of responding for a monetary reward on the EEfRT task and the score on our Rewarding Events scale. Other outcomes will be delay discounting results and self-reports of anhedonia and apathy.
The study will run for 1 week pre-cessation (2 visits) and then for 4 weeks post-cessation. Measures and biochemical verifications will occur twice/wk. Former smokers will attend once a wee for four weeks.
For the first week of abstinence, the cutoff for nonsmoking will be CO <8 ppm. For the remaining weeks, abstinence will be verified with a score of 0 (<10 ng/ml of cotinine) on a test strip in a saliva or urine sample plus a CO <8 ppm.
At the initial session, completion of baseline surveys will describe the sample and also measure plausible moderators such as depression.
We believe the most direct test of reward sensitivity is an evaluation of the influence of abstinence on operant responding for a reward. Thus, we have chosen performance on the Effort Expenditure for Rewards Task (EEfRT), which examines responding as a function of response cost, reward magnitude and probability of reward, as one of our primary outcomes.
For a self-report measure we will use our Rewarding Events (RE) scale that asks both about occurrence of presumed rewarding events and their anticipated pleasantness. Our RE scale will ask participants to rate 58 items on frequency in the last week as well perceived/expected pleasantness of events.
Secondary measures include the 18-item Apathy Evaluation Scale (AES), the Temporal Experience of Pleasure (TEPS), Minnesota Nicotine Withdrawal Scale-Revised (MNWS), and a measure of delay discounting (DD).
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
New Hampshire
-
Hanover, New Hampshire, Соединенные Штаты, 03755
- Dartmouth College
-
-
Vermont
-
Burlington, Vermont, Соединенные Штаты, 05401
- University of Vermont
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
For all participants:
- 18 yrs old or older
- able to read and understand verbal English fluently
- citizen or resident alien
- agree to abstain from illegal drugs during the study
For current smokers:
- currently smoke >10 cigarettes daily for > 1 yr
- want to quit smoking for good via abrupt cessation without treatment
- willing to quit 7-14 days from study entry and not reduce before quitting
- no reduction in cigs/day by >25% in the last month
- agree to no use of non-cigarette tobacco, non-tobacco nicotine, marijuana, illegal drugs, electronic cigarettes, or smoking cessation medications during the study
- have carbon monoxide (CO) level > or = 8 ppm at the time of consent
- no current use of prescribed psychoactive medications, including smoking cessation products.
For former smokers:
- smoked >10 cigarettes daily for > 1 yr
- quit at least 1 yr ago
- use of cigarettes or e-cigarettes 5 or fewer times in past year
- no tobacco or nicotine-containing product in last month
- agree to no use of non-cigarette tobacco, non-tobacco nicotine, marijuana, illegal drugs, electronic cigarettes, or smoking cessation medications during the study
- have carbon monoxide (CO) level < 8 ppm at the time of consent
- no current use of prescribed psychoactive medications, including smoking cessation products.
Exclusion Criteria for all participants:
- History of hand or wrist problems that could be exacerbated by study participation or interferes with completion of tasks
- current (last year) mood or alcohol/drug-related psychiatric disorder or any neurological condition that could influence reward sensitivity; e.g. Parkinsonism
- used marijuana 2 or more times in the last month
- problems with the use of alcohol or illegal drugs in the last 6 months
- currently pregnant
- use of smokeless tobacco
- lacking the use of one or both hands
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Smokers Cease Smoking
Participants are paid to quit smoking without using any medications.
|
Smokers are paid to be abstinent for four weeks, and stop-smoking medications may not be used.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Responses to Effort Expenditure for Rewards Task (EEfRT) Test
Временное ограничение: four weeks after quit date
|
The primary outcome will be the percent choosing the hard task and the amount of responding for a monetary reward on the EEfRT task.
|
four weeks after quit date
|
Rewarding Events Scale score.
Временное ограничение: four weeks after quit date
|
The score on our Rewarding Events scale.
|
four weeks after quit date
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Delayed Discounting
Временное ограничение: four weeks after quit date
|
Measures preference for immediate vs. delayed rewards by responses to several scenarios.
Outcome is a statistic that describes relative preference by time to reward.
|
four weeks after quit date
|
Self-reports of Anhedonia and Apathy
Временное ограничение: four weeks after quit date
|
Temporal Experience of Pleasure (TEPS) and Apathy Evaluation Scale (AES) both ask participants to rate pleasantness of common rewards.
Outcome is mean rating on ordinal scales.
Positive and Negative Affect Scale (PANAS) and the Minnesota Nicotine Withdrawal Scale-Revised (MNWS) ask participants to rate several mood or nicotine withdrawal symptoms.
Outcome is mean rating on 4 or 5 point ordinal scale.
|
four weeks after quit date
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования
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 (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CHRBS B11-185
- R01DA031687 (Грант/контракт NIH 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. .
Клинические исследования Smokers cease smoking
-
Massachusetts General HospitalFlight Attendant Medical Research InstituteЗавершенный
-
Istanbul Demiroglu Bilim UniversityЕще не набираютБезопасность пациентов | Тревога УсталостьТурция