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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

DOPE Trial Summary

This trial will test whether droperidol can effectively treat cannabinoid hyperemesis syndrome, a condition characterized by vomiting and abdominal pain.

Eligible Conditions
  • Cannabis Hyperemesis Syndrome

DOPE Trial Eligibility Criteria

Inclusion Criteria

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

DOPE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

DOPE 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does the FDA have to say about Diphenhydramine?

"There is some clinical data supporting Diphenhydramine's efficacy, and it has undergone multiple rounds of safety testing-- giving it a score of 3."

Answered by AI

How many individuals are being asked to participate in this research project?

"That is correct. The clinical trial indicated on clinicaltrials.gov is currently looking for 45 patients from 4 different centres. This research was originally posted on December 2nd, 2021 and updated February 16th, 2022."

Answered by AI

How many different places can people participate in this trial?

"This trial is currently being conducted at St Elizabeth Boardman Hospital in Boardman, St. Joseph-Warren Hospital in Warren, and St Elizabeth Youngstown Hospital in Youngstown - along with 4 other locations."

Answered by AI

Are patients still being recruited for this clinical trial?

"That is correct. The online clinicaltrials.gov database has information showing that this study is actively looking for patients to participate. This trial was first posted on December 2nd, 2021 and the most recent update was February 16th, 2022. There are 4 sites where 45 patients will be enrolled in total."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
Mercy Health - Austintown
What portion of applicants met pre-screening criteria?
Did not meet criteria
~14 spots leftby Mar 2025