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Dopamine Antagonist

Diphenhydramine for CHS (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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial

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
  • CHS

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 30 minutes, 60 minutes and 120 minutes. then at 24 hours and 48 hours.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 30 minutes, 60 minutes and 120 minutes. then at 24 hours and 48 hours. for reporting.

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 • NCT01967433
20%
Hypotension
8%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
8 Previous Clinical Trials
525 Total Patients Enrolled
Todd Bolotin, MDPrincipal InvestigatorMercy Health
2 Previous Clinical Trials
244 Total Patients Enrolled
~11 spots leftby Nov 2025
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