Probenecid, Pannexin 1 Channels for Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Acute Alcohol Craving
研究概览
简要总结
This study proposes a 16-week, between-subject, double-blind, randomized controlled trial (RCT) with probenecid (2g /day) compared to placebo in individuals with AUD to test if reduces craving and alcohol consumption.
详细描述
There are three aims in this study that test the hypothesis that probenecid compared to placebo, decreases:
- Aim 1 (laboratory phase): acute alcohol craving.
- Aim 2 (naturalistic phase): alcohol craving.
- Aim 3 (naturalistic phase): alcohol consumption
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Male or female, ≥18 years.
- •women >7 drinks/week; men >14 drinks/week.
- •meet moderate to severe AUD score for DSM-5 criteria.
- •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 positive urine test for pregnancy.
- •clinically significant medical abnormalities: unstable hypertension, clinically significant abnormal EKG, bilirubin >150% of the upper normal limit, ALT/AST >300% the UNL, creatinine clearance ≤60 dl/min
- •meet DSM-5 criteria for a diagnosis of schizophrenia, bipolar disorder, or other psychoses
- •medications that reduce alcohol consumption (naltrexone, disulfiram).
- •use aspirin (salicylates may reduce effect of probenecid), penicillin, methotrexate (may increase concentration).
- •history of suicide attempts in the last three years.
- •current diagnosis of a moderate or severe cannabis use disorder as assessed by self-report, SCID-E for SUD, and urine toxicology screen at baseline.
- •current diagnosis of another substance disorder at any severity, other than nicotine, as assessed by self-report, SCID-E for SUD, and urine toxicology screen at baseline.
- •current use of medications that may interact with probenecid.
- •history of hypersensitivity to sulfa drugs.
研究组 & 干预措施
Study drug
Probenecid 2gr oral
干预措施: Probenecid Oral Tablet (Drug)
Placebo
Placebo inactive
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Acute Alcohol Craving
时间窗: 5- week
Acute alcohol craving during an alcohol cue-reactivity procedure assessed using change in the alcohol urge questionnaire (AUQ). AUQ consists of eight statements about the respondent's feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). Drinking refers to various types of alcohol, including beer, wine and liquor. The respondent is asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from "strongly disagree" to "strongly agree." Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores. Minimum score is 7, maximum score is 48. Higher scores reflect greater alcohol craving (worse outcome)
次要结局
- Alcohol craving(12-week)
研究者
Carolina L Haass-Koffler
Associate Professor
Brown University