Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome
Kata kunci
Abstrak
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
Intervensi / pengobatan
Drug: Capsaicin
Drug: Placebo
Tahap
Kelompok Lengan
Lengan | Intervensi / 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 Belajar | All |
Menerima Relawan Sehat | Iya |
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)]
Ukuran Hasil Sekunder
1. Clinical improvement in pain score [1 day (During emergency department admission)]