NCT03398252撤回1 期
Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Feasibility as study attendance
研究概览
简要总结
Participants (N=10/group) will consist of non-treatment seeking individuals with AUD.
Following informed consent and baseline screening, participants will partake in 3 stress induction sessions to assess their stress levels and cravings for alcohol. Participants will be randomized to receive either increasing doses of doxazosin XL (0, 4, and 8 mg) or placebo in a double-blind manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet DSM-5 criteria for AUD;
- •Report excessive alcohol use as defined by CDC guidelines in the past month (>7 drinks/week for woman, >14 drinks/week for men, >3 drinks/occasion for women>4 drinks/occasion for men)3.
排除标准
- •Physical dependence on alcohol assessed using the SCID and Clinical Institute Withdrawal Assessment for Alcohol (CIWAA)
- •Presenting an Alcohol Use Disorders Inventory (AUDIT) score indicative of severe alcohol dependence (≥13 for women, ≥15 for men);
- •Meeting criteria for substance use disorder on drugs other than alcohol and nicotine;
- •Currently taking a prescribed psychoactive medication (e.g., atomoxetine for ADHD). In addition, exclusion for those individuals taking CYP3A4 inhibitors. Most participants will not be taking any concomitant medications (including over-the-counter supplements). For those who are taking an allowed medication, the study physician will determine if the medications are CYP3A4 inhibitors.
- •Medical conditions contraindicating doxazosin XL pharmacotherapy (e.g., postural hypotension);
- •Taking contraindicated medications such as blood pressure medications;
- •Be pregnant, nursing, or planning on becoming pregnant during the course of the study;
- •Have any other illness, condition, or use of medications, which in the opinion of the PI and/or admitting physician would preclude safe and/or successful completion of the study.
研究组 & 干预措施
Doxazosin XL
Experimental
Participants will receive increasing doses of doxazosin XL (0, 4, and 8 mg).
干预措施: Doxazosin XL (Drug)
Placebo
Placebo Comparator
Participants will be randomized to receive a placebo for doxazosin XL.
干预措施: Placebo (Drug)
结局指标
主要结局
Feasibility as study attendance
时间窗: Two weeks
Attending sessions
次要结局
- Stress as assessed by self-report(Friday of week 2)
- Stress as assessed by salivary cortisol levels(Friday of week 2)
- stress reactivity as assessed by increased blood pressure(Friday of week 2)
- Alcohol craving as assessed by the Penn Alcohol Craving Scale (PACS)(Friday of week 2)
- Alcohol Demand as assessed by the Brief Assessment of Alcohol Demand (BAAD) questionnaire(Friday of week 2)
- Stress as assessed by heart rate(Friday of week 2)
- Delay discounting for alcohol as assessed by a computerized task(Friday of week 2)
- Delay Discounting for money as assessed by a computerized task(Friday of week 2)
- Alcohol use as assessed by self-report(Friday of week 2)
研究者
Jin Ho Yoon
Assistant Professor
The University of Texas Health Science Center, Houston
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