A Phase IA Open Label Pharmaco- Magnetic Resonance Spectrography (MRS) Study of Clavulanic Acid Daily Repeated Administration in Remitted Cocaine Use Disorder Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Glutamate change from baseline
研究概览
简要总结
The main purpose of this study is to determine how the study drug, clavulanic acid, affects glutamate in the brain using Magnetic Resonance (MR/MRI) scans. In this study, subjects will receive the study drug, clavulanic acid and undergo 4 MRI scans. This is being studied to determine the correct dosing of clavulanic acid, and to gather data so future studies can be done to find out if this drug is helpful in treating cocaine dependence. Currently, there is no available medication treatment for cocaine dependence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 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 cocaine use disorder, moderate to severe in early remission.
- •Be male or female adult volunteers ages 18-65 inclusive.
- •If female and of childbearing potential, must have a negative pregnancy test within 48 hours of beginning the study and be willing to use acceptable contraception or be abstinent for 14 days prior to study, through the entire study and 30 days after study participation.
排除标准
- •Be unable to complete an MRI scan
- •(For full inclusion/exclusion criteria or for more information, please contact the site directly.)
研究组 & 干预措施
Open Label Clav
干预措施: Clavulanic Acid (Drug)
结局指标
主要结局
Glutamate change from baseline
时间窗: 10-17 Days
Change in brain glutamate concentration at Day 10-17 compared with baseline.
Glutamate/creatine ratio change from baseline
时间窗: 10-17 Days
Change in brain glutamate/creatine ratio at Day 10-17
次要结局
- Glutamate change after dose stoppage(Day 10-11)
- Change in brain glutamine/creatine ratio from baseline(10-17 Days)
- Glutamate/creatine ratio change after dose stoppage(Day 10-11)
- Change in brain glutamine from baseline(10-17 Days)
- Number of participants with treatment-related adverse events (AEs) as assessed by comprehensive metabolic panel, complete blood count, ekg, urinalysis, C-SSRS, and any self-reported change in health.(1-31 days (during and after study dosing period))