Probenecid as Pharmacotherapy for Alcohol Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo
研究概览
简要总结
The design is a randomized, within-subject, crossover, double-blind, placebo-controlled human alcohol laboratory study with one oral dose of 2g probenecid or placebo administered in two laboratory sessions.
详细描述
There will be a total of four study visits. Visit 1 is the screening for eligibility (medical and physical examination). On Visits 2 and 3, participants will undergo an alcohol laboratory session with a one week washout period before administering the alternate therapy. The study will conclude at Visit 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 21-70 (inclusive) years; women >7 drinks/week; men >14 drinks/week;
- •meet any DSM-5 criteria score for AUD;
- •Breath alcohol Content (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
排除标准
- •Women who are breastfeeding or have a positive urine screen for pregnancy
- •CrCl < 60mL/min
- •Taking aspirin (salicylates may reduce effect of probenecid)
- •Taking penicillin
- •Taking methotrexate (may increase concentration)
- •Taking other medications that may interact with probenecid
- •History of suicide attempts in the last three years
- •Current diagnosis of another substance disorder(s) other than nicotine, as assessed by self-reports and urine toxicology screen at baseline
- •History of hypersensitivity to sulfa drugs
研究组 & 干预措施
Probenecid
2g probenecid, one pill by mouth once, for one day
干预措施: Probenecid or placebo single administration (Drug)
matching placebo
Placebo, one pill by mouth once, for one day
干预措施: Probenecid or placebo single administration (Drug)
结局指标
主要结局
Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo
时间窗: Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).
The stimulant effect of alcohol is assessed using the Biphasic Alcohol Effects Scale (BAES). The BAES is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of 14 items (score) that are rated on a 11-point scale. 7 of the 14 items comprise the stimulation subscale. Individuals are instructed to rate the extent to which alcohol has produced these feelings at the present time from minimum=0 to maximum=10. The subscale of stimulation has a minimum score of 0 (not at all, best outcome) and a maximum score of 70 (high, worse outcome). The scale was validated and published: Martin, C. S., Earleywine, M., Musty, R. E., Perrine, M. W. \& Swift R. M. (1993). Development and Validation of the Biphasic Alcohol Effects Scale. Alcoholism: Clinical and Experimental Research, 17, 140-146.
次要结局
- Sedative Effects of Alcohol When Co-administered With Drug or Matching Placebo(Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).)
- Alcohol Craving(Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).)
研究者
Carolina L Haass-Koffler
Assistant Professor
Brown University