Haloperidol For Outpatient Symptom Management in Patients Diagnosed With Cannabinoid Hyperemesis Syndrome in the Emergrency Department
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of return to the emergency department
研究概览
简要总结
Patients diagnosed with cannabinoid hyperemesis syndrome that are safe for discharge from the emergency department will be sent an outpatient prescription for haloperidol to be used as needed at home. The study goal is to see if having this medication available helps to prevent return emergency department visits for recurrent or persistent symptoms.
详细描述
Cannabinoid hyperemesis syndrome is a relatively new syndrome characterized by nausea, vomiting, and abdominal pain in the setting of excessive cannabis use. This clinical entity has become increasingly prevalent as the concentration of THC has increased in marijuana products over the past several decades. The symptoms have been treated successfully with several medications however the most efficacious appears to be dopamine antagonists such as haloperidol and droperidol. These dopamine antagonists have been used safely and successfully in the inpatient and emergency department settings to decrease the frequency and intensity of nausea, vomiting, and abdominal pain in patients suffering from cannabinoid hyperemesis syndrome. The investigators plan to evaluate haloperidol, a dopamine antagonist available as an oral formulation, as an option for outpatient management of these symptoms.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must meet ALL of the following criteria:
- •Age ≥ 18 years
- •Primary ED complaints of acute or episodic nausea, vomiting, and/or abdominal pain
- •Self reported frequent cannabis use
- •Patients must meet at least TWO of the following criteria:
- •History of recurrent, cyclical episodes of severe nausea and vomiting
- •Self-reported temporary symptom relief with hot showers or baths
- •Symptom onset or exacerbation following cannabis consumption
排除标准
- •Patients with imaging or lab findings suggestive of an alternative etiology that would explain their symptoms
- •Already on dopamine agonist/antagonist therapy for another condition
- •Parkinson's disease
- •Lewy body dementia
- •Men with QTc > 450
- •Women with QTc > 460
- •Patients with documented allergy to haloperidol
- •Patients with known functional prolactinomas
- •Patients who are breastfeeding
- •Patients under the age of 18
- •Patients who are pregnant
- •Patients who are in the prison system
- •Patients who are unable to consent
研究组 & 干预措施
Patients who will receive haloperidol
Patients in this arm of the study will receive haloperidol to be used as needed on an outpatient basis
干预措施: Haloperidol (Drug)
结局指标
主要结局
Rate of return to the emergency department
时间窗: 1 month
The investigators plan to measure the percentage of people who return to the emergency department for recurrence of symptoms attributable to cannabinoid hyperemesis syndrome
次要结局
- Improvement in symptoms(1 month)
- Medication side effects(1 month)
研究者
Mason Bartman
MD
University of Illinois at Chicago