酒精使用障碍的 Alpha-1 阻断剂 (AUD) (DOXY)
关注 Alpha-1 封锁作为 AUD 的新型药物治疗
The goal of this research is to replicate findings previously conducted in a pilot trial and to understand, mechanistically, the role of stress in the development of AUD pharmacotherapies that target noradrenergic blockade.
研究概览
详细说明
16 week, between-subject, double-blind, randomized clinical trial (RCT) with doxazosin (16 mg, or maximum tolerated dose, MTD) compared to placebo in 184 treatment seeking individuals with AUD
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习地点
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-
Rhode Island
-
Providence、Rhode Island、美国、20923
- Brown University
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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:
- Male or female, 18 years of age
- Meet the DSM-5 criteria for AUD
- Desire to reduce or quit alcohol drinking
- Breath alcohol (BrAC) = 0.00 at each visit
- In good health as confirmed by medical history, physical examination and lab tests
- Willing to adhere to the study procedures
- Understand informed consent and questionnaires in English at an 8th grade level
Exclusion Criteria:
- Women who are breastfeeding or /positive urine test for pregnancy
- CrCl<60mL/min
- Suicide attempt in the last three months
- Current diagnosis of other substance disorder other than nicotine as assessed by self-report and urine toxicology screen at baseline
- Current use of medication that may interact with doxazosin and/or yohimbine
- History of allergy to any alpha receptor blockers
- Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) score ≥ 8
- Treatment with disulfiram, naltrexone, acamprosate, topiramate within 1 month prior to screening
- Treatment with any alpha-blocker
- Individuals with cardiac heat failure (CHF), as assessed by the medical history, the physical exam and the ECG.
- Baseline hypotension defined as BP reading lower than 90/60 mmHg
- Use of phosphodiesterase inhibitors (PDE5) erectile dysfunction medication
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:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:doxazosin
16 mg, or maximum tolerated dose (MTD) |
16 mg or maximum tolerated dose (MTD)
其他名称:
|
|
安慰剂比较:placebo
matching placebo |
Matching placebo |
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 consumption
大体时间:6 weeks
|
Number of drinks per week (DPW) in naturalistic condition as measured by the timeline follow-back (TLFB) |
6 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Alcohol craving
大体时间:one day
|
We will measure alcohol craving using the Alcohol Craving Questionnaire (ACQ) after a cue-reactivity |
one day
|
|
Alcohol craving
大体时间:six weeks
|
Alcohol craving in naturalistic condition will be measured using craving the Obsessive Compulsive Drinking Scale (OCDS) |
six weeks
|
合作者和调查者
调查人员
- 首席研究员:Carolina L Haass-Koffler, PHARMD, PHD、Brown University
出版物和有用的链接
一般刊物
- Haass-Koffler CL, Goodyear K, Zywiak WH, Magill M, Eltinge SE, Wallace PM, Long VM, Jayaram-Lindstrom N, Swift RM, Kenna GA, Leggio L. Higher pretreatment blood pressure is associated with greater alcohol drinking reduction in alcohol-dependent individuals treated with doxazosin. Drug Alcohol Depend. 2017 Aug 1;177:23-28. doi: 10.1016/j.drugalcdep.2017.03.016. Epub 2017 May 16.
- Kenna GA, Haass-Koffler CL, Zywiak WH, Edwards SM, Brickley MB, Swift RM, Leggio L. Role of the alpha1 blocker doxazosin in alcoholism: a proof-of-concept randomized controlled trial. Addict Biol. 2016 Jul;21(4):904-14. doi: 10.1111/adb.12275. Epub 2015 Jun 2.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
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
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