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Dopamine Antagonist
Diphenhydramine for Cannabis Hyperemesis Syndrome (DOPE Trial)
Phase 3
Recruiting
Led By Todd Bolotin, MD
Research Sponsored by Mercy Health Ohio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* aged 18 years of age or older and presenting with cannabis hyperemesis syndrome requiring intravenous medication.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 30 minutes, 60 minutes and 120 minutes. then at 24 hours and 48 hours.
Awards & highlights
Summary
This trial tests droperidol and diphenhydramine to treat patients with severe nausea and vomiting due to heavy cannabis use. Droperidol blocks signals in the brain that cause nausea, while diphenhydramine calms the patient and prevents allergic reactions. Droperidol is an antipsychotic drug that has been used and studied as an antiemetic in the management of post-operative and chemotherapy nausea and vomiting.
Eligible Conditions
- Cannabis Hyperemesis Syndrome
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 30 minutes, 60 minutes and 120 minutes. then at 24 hours and 48 hours.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 30 minutes, 60 minutes and 120 minutes. then at 24 hours and 48 hours.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in symptoms after treatment with droperidol and diphenhydramine
Side effects data
From 2018 Phase 4 trial • 120 Patients • NCT0196743320%
Hypotension
8%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment2 Interventions
Patients who receive droperidol 2.5mg intravenous once and diphenhydramine 25mg intravenous once
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diphenhydramine
FDA approved
Find a Location
Who is running the clinical trial?
Mercy Health OhioLead Sponsor
14 Previous Clinical Trials
1,560 Total Patients Enrolled
Lake Erie College of Osteopathic MedicineOTHER
7 Previous Clinical Trials
485 Total Patients Enrolled
Todd Bolotin, MDPrincipal InvestigatorMercy Health
2 Previous Clinical Trials
244 Total Patients Enrolled
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