Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome
关键词
抽象
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
干预/治疗
Drug: Capsaicin
Drug: Placebo
相
手臂组
臂 | 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 | 是 |
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)]
次要成果指标
1. Clinical improvement in pain score [1 day (During emergency department admission)]