Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time to resolution of symptoms
研究概览
简要总结
This study aims to determine if capsaicin cream offers symptomatic relief to patients suffering from Cannabinoid Hyperemesis Syndrome (condition that leads to repeated and severe bouts of vomiting).
详细描述
Objectives:
The purpose of this study is to determine if capsaicin cream offers symptomatic relief to patients suffering from Cannabinoid Hyperemesis Syndrome. We hypothesize that the use of topical capsaicin may provide effective symptomatic relief more quickly than conventional anti-emetic therapy alone thereby decreasing costs for continued drug therapies, repeat laboratory testing, radiographic imaging, and specialist consults.
Primary endpoint:
Time to resolution of symptoms, clinical improvement in pain score as defined by visual analog score.
Approach and methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
盲法说明
investigational pharmacists and designated personell will the only unblinded study staff.
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
- •At least 18 years old
- •Diagnosis of cannabinoid hyperemesis syndrome
排除标准
- •Patients who receive more than 2 anti-emetic therapies prior to screening for enrollment
- •Patients who receive haloperidol as an anti-emetic therapy
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Capsaicin
capsaicin 0.075% cream applied once topically
干预措施: Capsaicin (Drug)
Placebo
placebo cream applied once topically
干预措施: Placebo (Drug)
结局指标
主要结局
Time to resolution of symptoms
时间窗: 1 day (During emergency department admission)
Time that it takes for symptoms to be resolved for those with Cannabinoid Hyperemesis Syndrome
次要结局
- Clinical improvement in pain score(1 day (During emergency department admission))
研究者
Angela Holian
Emergency Medicine Clinical Pharmacist
University of Virginia