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Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

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University of Virginia

关键词

抽象

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).

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:

Patients presenting to the UVA Emergency Department with chief complaint of nausea and vomiting who endorse cannabinoid use via inhalation or consumption. Patients 18 years of age and older will be included in the study and patients who have another clear indication for nausea/vomiting or cyclic vomiting (infection, appendicitis, pain, etc.) will be excluded. Patients who are enrolled in the study will be randomized 1:1 to treatment vs. placebo. All patients will be allowed 1L of intravenous fluids and one to two standard anti-emetics. The Investigational Drug Services team at UVA will be involved in compounding the capsaicin treatment versus placebo and drug/placebo shall remain in place for at least 30 minutes. Clinical improvement will be scored based on visual analog score for pain and assessment at hourly increments until discharge or admission.

日期

最后验证: 01/31/2020
首次提交: 02/20/2020
提交的预估入学人数: 02/23/2020
首次发布: 02/24/2020
上次提交的更新: 02/24/2020
最近更新发布: 02/26/2020
实际学习开始日期: 02/29/2020
预计主要完成日期: 02/28/2022
预计完成日期: 12/30/2022

状况或疾病

Cannabinoid Hyperemesis Syndrome

干预/治疗

Drug: Capsaicin

Drug: Placebo

相 4

手臂组

干预/治疗
Experimental: Capsaicin
capsaicin 0.075% cream applied once topically
Drug: Capsaicin
Topical Capsaicin for the treatment of Cannabinoid Hyperemesis Syndrome
Active Comparator: Placebo
placebo cream applied once topically
Drug: Placebo
Placebo cream that is applied once topically

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
接受健康志愿者
标准

Inclusion Criteria:

- At least 18 years old

- Diagnosis of cannabinoid hyperemesis syndrome

Exclusion Criteria:

- 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

结果

主要结果指标

1. Time to resolution of symptoms [1 day (During emergency department admission)]

Time that it takes for symptoms to be resolved for those with Cannabinoid Hyperemesis Syndrome

次要成果指标

1. Clinical improvement in pain score [1 day (During emergency department admission)]

Clinical improvement in pain score as defined by visual analog score with a scale from 0-10 where is 0 is no pain and 10 is unbearable pain. Pain should decrease over time and this will be measure by the visual analog scale

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