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Дексаметазон воздействует на стресс и механизмы иммунной системы, лежащие в основе тяги к алкоголю

28 сентября 2026 г. обновлено: Helen Fox, Stony Brook University

Дексаметазон для борьбы со стрессом и изменениями иммунной системы во время ранней абстиненции у людей с расстройствами, связанными с употреблением алкоголя (AUD)

This is a double-blind, placebo-controlled, proof of concept laboratory study to recruit N=70 (35 Males / 35 Females) non-treatment seeking, heavy drinkers with alcohol use disorder (AUD). It is hypothesized that randomization to 1.5mgs dexamethasone versus placebo will decrease alcohol craving during stress by decreasing basal cortisol, increasing anti-inflammatory cytokine levels and potentially normalizing the immune response to stress.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

27

Фаза

  • Ранняя фаза 1

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 55 лет (Взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • Non-treatment seeking heavy drinking men and women with AUD
  • Age range 18-55,
  • Body Mass Index (BMI) of 18-35
  • Positive ethylglucuronide (EtG) urine toxicology screen for alcohol
  • Able to provide informed written and verbal consent
  • Able to read English and complete study evaluations
  • Good health as verified by screening examination.

Exclusion Criteria:

  • Meet criteria for Substance Use Disorder (SUD) or other psychoactive substances, excluding nicotine
  • Unable to remain abstinent for five days
  • Need for a medically assisted detoxification
  • Regular use of steroids, anticonvulsants, sedatives/hypnotics, prescription analgesics, other anti-hypertensives, anti-arrythmics, antiretroviral medications, tricyclic antidepressants, naltrexone, disulfiram, and any other psychoactive medications with the exception of stabilization on Selective Serotonin Re-uptake Inhibitors (SSRIs)
  • Psychotic or severely psychiatrically disabled
  • Significant underlying medical conditions which would be of potential harm
  • Pregnancy or breast feeding women;
  • Women using monophasic contraceptives
  • Electrocardiogram (EKG) evidence of clinically significant conduction abnormalities, (Bazlett's corrected QT (QTc) interval of >450 msec for men and QTc>470 msec for women).

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: Guanfacine

single dose of dexamethasone (1.5mg) administered orally
Лекарство: Dexamethasone Oral

1.5mg oral dexamethasone to be administered once at 11:00PM

Другие имена:
  • Декадрон, Дексаметазон Интенсол, Дексазон, Солурекс и Байкадрон.
Плацебо Компаратор: Placebo

single dose of placebo administered orally
Лекарство: Placebo

oral placebo to be administered once at 11:00PM

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Alcohol craving as assessed using subjective report following stress exposure
Временное ограничение: Change from baseline to +5 minutes following stress exposure

The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Change from baseline to +5 minutes following stress exposure
Alcohol craving as assessed using subjective report following stress exposure
Временное ограничение: Change from baseline to +15 minutes following stress exposure

The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Change from baseline to +15 minutes following stress exposure
Alcohol craving as assessed using subjective report following stress exposure
Временное ограничение: Change from baseline to +30 minutes following stress exposure

The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Change from baseline to +30 minutes following stress exposure
Alcohol craving as assessed using subjective report following stress exposure
Временное ограничение: Change from baseline to +5 minutes following stress exposure

A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Change from baseline to +5 minutes following stress exposure
Alcohol craving as assessed using subjective report following stress exposure
Временное ограничение: Change from baseline to +15 minutes following stress exposure

A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Change from baseline to +15 minutes following stress exposure
Alcohol craving as assessed using subjective report following stress exposure
Временное ограничение: Change from baseline to +30 minutes following stress exposure

A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Change from baseline to +30 minutes following stress exposure
Hypothalamic-Pituitary-Adrenal (HPA)-axis response to stress exposure as assessed by cortisol
Временное ограничение: Change from baseline to +5 minutes following stress exposure

4mls of plasma cortisol will be collected following exposure to stress
Change from baseline to +5 minutes following stress exposure
HPA axis response to stress exposure as assessed by cortisol
Временное ограничение: Change from baseline to +15 minutes following stress exposure

4mls of plasma cortisol will be collected following exposure to stress
Change from baseline to +15 minutes following stress exposure
HPA axis response to stress exposure as assessed by cortisol
Временное ограничение: Change from baseline to +30 minutes following stress exposure

4mls of plasma cortisol will be collected following exposure to stress
Change from baseline to +30 minutes following stress exposure
HPA axis response to stress exposure as assessed by Adrenocorticotropic Hormone (ACTH)
Временное ограничение: Change from baseline to +5 minutes following stress exposure

4mls of plasma ACTH will be collected following exposure to stress
Change from baseline to +5 minutes following stress exposure
HPA axis response to stress exposure as assessed by ACTH
Временное ограничение: Change from baseline to +15 minutes following stress exposure

4mls of plasma ACTH will be collected following exposure to stress
Change from baseline to +15 minutes following stress exposure
HPA axis response to stress exposure as assessed by ACTH
Временное ограничение: Change from baseline to +30 minutes following stress exposure

4mls of plasma ACTH will be collected following exposure to stress
Change from baseline to +30 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Временное ограничение: Change from baseline to +5 minutes following stress exposure

4mls of plasma Interleukin (IL)-10 will be collected following exposure to stress
Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Временное ограничение: Change from baseline to +15 minutes following stress exposure

4mls of plasma IL-10 will be collected following exposure to stress
Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Временное ограничение: Change from baseline to +30 minutes following stress exposure

4mls of plasma IL-10 will be collected following exposure to stress
Change from baseline to +30 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Временное ограничение: Change from baseline to +5 minutes following stress exposure

4mls of plasma Interleukin 1 receptor antagonist (IL1-ra) will be collected following exposure to stress
Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Временное ограничение: Change from baseline to +15 minutes following stress exposure

4mls of plasma IL1-ra will be collected following exposure to stress
Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Временное ограничение: Change from baseline to +30 minutes following stress exposure

4mls of plasma IL1-ra will be collected following exposure to stress
Change from baseline to +30 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Временное ограничение: Change from baseline to +5 minutes following stress exposure

4mls of plasma IL-6 will be collected following exposure to stress
Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Временное ограничение: Change from baseline to +15 minutes following stress exposure

4mls of plasma IL-6 will be collected following exposure to stress
Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Временное ограничение: Change from baseline to +30 minutes following stress exposure

4mls of plasma IL-6 will be collected following exposure to stress
Change from baseline to +30 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Временное ограничение: Change from baseline to +5 minutes following stress exposure

4mls of plasma Tumor Necrosis Factor alpha (TNFa) will be collected following exposure to stress
Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Временное ограничение: Change from baseline to +15 minutes following stress exposure

4mls of plasma TNFa will be collected following exposure to stress
Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Временное ограничение: Change from baseline to +30 minutes following stress exposure

4mls of plasma TNFa will be collected following exposure to stress
Change from baseline to +30 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Временное ограничение: Change from baseline to +5 minutes following stress exposure

4mls of plasma Tumor Necrosis Factor Receptor 1 (TNFR1) will be collected following exposure to stress
Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Временное ограничение: Change from baseline to +15 minutes following stress exposure

4mls of plasma TNFR1 will be collected following exposure to stress
Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Временное ограничение: Change from baseline to +30 minutes following stress exposure

4mls of plasma TNFR1 will be collected following exposure to stress
Change from baseline to +30 minutes following stress exposure

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Anxiety as assessed using subjective report following stress exposure
Временное ограничение: Change from baseline to +5 minutes following stress exposure

A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Change from baseline to +5 minutes following stress exposure
Anxiety as assessed using subjective report following stress exposure
Временное ограничение: Change from baseline to +15 minutes following stress exposure

A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Change from baseline to +15 minutes following stress exposure
Anxiety as assessed using subjective report following stress exposure
Временное ограничение: Change from baseline to +30 minutes following stress exposure

A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Change from baseline to +30 minutes following stress exposure
Negative Mood as assessed using subjective report following stress exposure
Временное ограничение: Change from baseline to +5 minutes following stress exposure

The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely
Change from baseline to +5 minutes following stress exposure
Negative Mood as assessed using subjective report following stress exposure
Временное ограничение: Change from baseline to +15 minutes following stress exposure

The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely
Change from baseline to +15 minutes following stress exposure
Negative Mood as assessed using subjective report following stress exposure
Временное ограничение: Change from baseline to +30 minutes following stress exposure

The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely
Change from baseline to +30 minutes following stress exposure

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Stony Brook University

Следователи

  • Главный следователь: Helen C Fox, PhD, Indiana University School of Medicine, Dept. of Psychiatry

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

11 марта 2022 г.

Первичное завершение (Действительный)

23 июня 2024 г.

Завершение исследования (Действительный)

30 июня 2024 г.

Даты регистрации исследования

Первый отправленный

22 марта 2022 г.

Впервые представлено, что соответствует критериям контроля качества

22 марта 2022 г.

Первый опубликованный (Действительный)

31 марта 2022 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

2 октября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

28 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • R21AA029735 (Грант/контракт NIH США)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Нет

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. .

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