地塞米松靶向酒精渴望的压力和免疫系统机制
地塞米松针对酒精使用障碍 (AUD) 患者早期戒酒期间的压力和免疫系统变化
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.
研究概览
研究类型
注册 (实际的)
阶段
- 第一阶段早期
联系人和位置
学习地点
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New York
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Stony Brook、New York、美国、11794
- The Health Sciences Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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).
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Guanfacine
single dose of dexamethasone (1.5mg) administered orally |
1.5mg oral dexamethasone to be administered once at 11:00PM
其他名称：
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安慰剂比较：Placebo
single dose of placebo administered orally |
oral placebo to be administered once at 11:00PM |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Alcohol craving as assessed using subjective report following stress exposure
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Anxiety as assessed using subjective report following stress exposure
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
调查人员
- 首席研究员：Helen C Fox, PhD、Indiana University School of Medicine, Dept. of Psychiatry
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- R21AA029735 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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