Cannabis Hyperemesis SyndromePhase 3DOPENCT05244460
Droperidol on Prevention of Cannabis Hyperemesis Syndrome
A Phase 3 study testing Droperidol Injectable Product and Diphenhydramine in people with Cannabis Hyperemesis Syndrome, run by Mercy Health Ohio at 4 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy of droperidol as a treatment of cannabinoid hyperemesis syndrome. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cannabis Hyperemesis Syndrome
- What is being tested?
- Droperidol Injectable Product and Diphenhydramine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Dec 2021to 31 Jan 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 years of age or older and presenting with cannabis hyperemesis syndrome requiring intravenous medication.
Who cannot join
- any patient with a contraindication to the use of droperidol
- Corrected QT interval on ECG greater than 440 milliseconds for males and greater than 450 milliseconds for females
- any prisoners
- pregnant females.
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Mercy Health - Austintown
Austintown, Ohio, 44515
Benjamin Pugsley, DO, 619-972-5453, bpugsley1@mercy.com
- Recruiting
St Elizabeth Boardman Hospital
Boardman, Ohio, 44512
Joseph Noga, DO, 724-944-7500, jnoga@mercy.com
- Recruiting
St. Joseph-Warren Hospital
Warren, Ohio, 44484
Benjamin Pugsley, DO, 619-972-5453, bpugsley1@mercy.com
- Recruiting
St Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501
Chad Donley, MD, 330-729-7960, chad_donley1@mercy.com
About this study
Official title: Droperidol on Prevention of Emesis From Cannabinoid Hyperemesis Syndrome
The purpose of this study is to assess the efficacy of droperidol as a treatment of cannabinoid hyperemesis syndrome.
Read the detailed description
Patients presenting to the Emergency Department with nausea, vomiting and/or abdominal pain with a significant history of cannabis use and symptoms in a cyclic pattern will be assessed for study inclusion. After given written informed consent, patients will be treated with droperidol and diphenhydramine and symptoms will be assessed using a visual analog scale at time intervals up to 120 minutes. Patient will then be contacted at 24 and 48 hour intervals to assess symptoms on the same scale. This is a multicenter, prospective interventional study with results compared to a historical cohort using haloperidol.
- Conditions
- Cannabis Hyperemesis Syndrome
- Being tested
- Droperidol Injectable Product, Diphenhydramine
- Medical subject headings
- Cannabinoid Hyperemesis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Droperidol Injectable ProductDrug
Also called Inapsine
Treatment
DiphenhydramineDrug
Also called Benadryl
Treatment
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients who receive droperidol 2.5mg intravenous once and diphenhydramine 25mg intravenous once Receives: Drug: Droperidol Injectable Product; Drug: Diphenhydramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in symptoms after treatment with droperidol and diphenhydramine
The Visual Analog Scale is a 100-mm patient-reported score measurement used to assess nausea and/or vomiting and/or abdominal pain. Possible scores range from 0 (symptom-free) to 10 (worst possible symptom)
Measured: Baseline, 30 minutes, 60 minutes and 120 minutes. Then at 24 hours and 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start2 Dec 2021
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cannabis Hyperemesis SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mercy Health Ohio
- Sponsor type
- University, hospital or other
- Collaborators
- Lake Erie College of Osteopathic Medicine
- Responsible party
- Sponsor
- Investigators
- Todd Bolotin, MD, Principal investigator, Mercy Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244460
- Sponsor's protocol ID
- 21-029
- Acronym
- DOPE
- Status last verified
- Jan 2023
- First submitted
- 7 Feb 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruberto AJ, Sivilotti MLA, Forrester S, Hall AK, Crawford FM, Day AG. Intravenous Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC): A Randomized, Controlled Trial. Ann Emerg Med. 2021 Jun;77(6):613-619. doi: 10.1016/j.annemergmed.2020.08.021. Epub 2020 Nov 5.
PubMed 33160719Lee C, Greene SL, Wong A. The utility of droperidol in the treatment of cannabinoid hyperemesis syndrome. Clin Toxicol (Phila). 2019 Sep;57(9):773-777. doi: 10.1080/15563650.2018.1564324. Epub 2019 Feb 7.
PubMed 30729854Hickey JL, Witsil JC, Mycyk MB. Haloperidol for treatment of cannabinoid hyperemesis syndrome. Am J Emerg Med. 2013 Jun;31(6):1003.e5-6. doi: 10.1016/j.ajem.2013.02.021. Epub 2013 Apr 10.
PubMed 23583118
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Droperidol on Prevention of Emesis From Cannabinoid Hyperemesis Syndrome
- ClinicalTrials.gov ID
- NCT05244460
- Acronym / sponsor ID
- DOPE / 21-029
- Conditions
- Cannabis Hyperemesis Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Mercy Health OhioUniversity, hospital or other
- Collaborators
- Lake Erie College of Osteopathic Medicine
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy of droperidol as a treatment of cannabinoid hyperemesis syndrome.
Detailed description
Patients presenting to the Emergency Department with nausea, vomiting and/or abdominal pain with a significant history of cannabis use and symptoms in a cyclic pattern will be assessed for study inclusion. After given written informed consent, patients will be treated with droperidol and diphenhydramine and symptoms will be assessed using a visual analog scale at time intervals up to 120 minutes. Patient will then be contacted at 24 and 48 hour intervals to assess symptoms on the same scale. This is a multicenter, prospective interventional study with results compared to a historical cohort using haloperidol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Droperidol Injectable Product, Drug: DiphenhydraminePatients who receive droperidol 2.5mg intravenous once and diphenhydramine 25mg intravenous once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 18 years of age or older and presenting with cannabis hyperemesis syndrome requiring intravenous medication.
Key exclusion criteria (4 listed)
- any patient with a contraindication to the use of droperidol
- Corrected QT interval on ECG greater than 440 milliseconds for males and greater than 450 milliseconds for females
- any prisoners
- pregnant females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Droperidol Injectable ProductAlso: InapsineTreatment | Drug | Intervention |
| DiphenhydramineAlso: BenadrylTreatment | Drug | Intervention |
Primary outcome
Change from baseline in symptoms after treatment with droperidol and diphenhydramine
Time frame: Baseline, 30 minutes, 60 minutes and 120 minutes. Then at 24 hours and 48 hours.
The Visual Analog Scale is a 100-mm patient-reported score measurement used to assess nausea and/or vomiting and/or abdominal pain. Possible scores range from 0 (symptom-free) to 10 (worst possible symptom)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Background: PubMed 33160719Ruberto AJ, Sivilotti MLA, Forrester S, Hall AK, Crawford FM, Day AG. Intravenous Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC): A Randomized, Controlled Trial. Ann Emerg Med. 2021 Jun;77(6):613-619. doi: 10.1016/j.annemergmed.2020.08.021. Epub 2020 Nov 5.
- Background: PubMed 30729854Lee C, Greene SL, Wong A. The utility of droperidol in the treatment of cannabinoid hyperemesis syndrome. Clin Toxicol (Phila). 2019 Sep;57(9):773-777. doi: 10.1080/15563650.2018.1564324. Epub 2019 Feb 7.
- Background: PubMed 23583118Hickey JL, Witsil JC, Mycyk MB. Haloperidol for treatment of cannabinoid hyperemesis syndrome. Am J Emerg Med. 2013 Jun;31(6):1003.e5-6. doi: 10.1016/j.ajem.2013.02.021. Epub 2013 Apr 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Bolotin, MD principal investigator
Mercy Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Droperidol Injectable Product and Diphenhydramine in people with Cannabis Hyperemesis Syndrome, run by Mercy Health Ohio at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Todd Bolotin, MD (3302193838, tbolotin@mercy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in symptoms after treatment with droperidol and diphenhydramine (time frame: Baseline, 30 minutes, 60 minutes and 120 minutes. Then at 24 hours and 48 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05244460, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.