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Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

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StatusBelum merekrut
Sponsor
University of Virginia

Kata kunci

Abstrak

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).

Deskripsi

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.

tanggal

Terakhir Diverifikasi: 01/31/2020
Pertama Dikirim: 02/20/2020
Perkiraan Pendaftaran Telah Dikirim: 02/23/2020
Pertama Diposting: 02/24/2020
Pembaruan Terakhir Dikirim: 02/24/2020
Pembaruan Terakhir Diposting: 02/26/2020
Tanggal Mulai Studi Sebenarnya: 02/29/2020
Perkiraan Tanggal Penyelesaian Utama: 02/28/2022
Perkiraan Tanggal Penyelesaian Studi: 12/30/2022

Kondisi atau penyakit

Cannabinoid Hyperemesis Syndrome

Intervensi / pengobatan

Drug: Capsaicin

Drug: Placebo

Tahap

Tahap 4

Kelompok Lengan

LenganIntervensi / pengobatan
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

Kriteria kelayakan

Usia yang Layak untuk Belajar 18 Years Untuk 18 Years
Jenis Kelamin yang Layak untuk BelajarAll
Menerima Relawan SehatIya
Kriteria

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

Hasil

Ukuran Hasil Utama

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

Ukuran Hasil Sekunder

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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