Haloperidol For Outpatient Symptom Management in Patients Diagnosed With Cannabinoid Hyperemesis Syndrome in the Emergrency Department
2026年8月30日 更新者:Mason Bartman、University of Illinois at Chicago
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
100
阶段
- 第一阶段早期
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Mason A Bartman, MD
- 电话号码:8178972205
- 邮箱:mbartman@uic.edu
研究联系人备份
- 姓名:Wesley Eilbert, MD
- 电话号码:6302944225
- 邮箱:weilbert@uic.edu
学习地点
-
-
Illinois
-
Chicago、Illinois、美国、60612
- University of Illinois Hospital
-
接触:
- Mason A Bartman, MD
- 电话号码:8178972205
- 邮箱:mbartman@uic.edu
-
接触:
- Wesley Eilbert, MD
- 电话号码:6302944225
- 邮箱:weilbert@uic.edu
-
首席研究员:
- Mason A Bartman, MD
-
首席研究员:
- Wesley Eilbert, MD
-
副研究员:
- Shaveta Khosla, Khosla
-
副研究员:
- Drew Posen, PharmD
-
副研究员:
- Urvi Dubey, BS
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Patients who will receive haloperidol
Patients in this arm of the study will receive haloperidol to be used as needed on an outpatient basis
|
This intervention involves providing patients an outpatient prescription for as needed haloperidol to attempt to control symptoms of cannabinoid hyperemesis and to attempt to prevent return to the emergency department for that reason.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of return to the emergency department
大体时间: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
|
1 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Improvement in symptoms
大体时间:1 month
|
The investigators plan to report patient reported change in symptoms attributable to cannabinoid hyperemesis syndrome.
The subjects will report change in their symptoms via a 5 point likert scale with 1 being no change in symptoms at all and 5 being complete resolution of symptoms.
|
1 month
|
|
Medication side effects
大体时间:1 month
|
The investigators plan to report the rate of patient reported side effects that are considered attributable to cannabinoid hyperemesis syndrome
|
1 month
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Wesley Eilbert, MD、University of Illinois Health
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年11月1日
初级完成 (估计的)
2028年1月1日
研究完成 (估计的)
2028年1月1日
研究注册日期
首次提交
2026年7月21日
首先提交符合 QC 标准的
2026年7月21日
首次发布 (实际的)
2026年7月24日
研究记录更新
最后更新发布 (实际的)
2026年9月1日
上次提交的符合 QC 标准的更新
2026年8月30日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2026-0693
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
The investigators don't need to share IPD with anyone outside of investigators in this clinical trial to complete this trial.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.