Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-31 @ 11:04 PM
Study NCT ID:
NCT05244460
Status:
UNKNOWN
Last Update Posted:
2023-01-20
First Post:
2022-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Droperidol on Prevention of Cannabis Hyperemesis Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096704', 'term': 'Cannabinoid Hyperemesis Syndrome'}], 'ancestors': [{'id': 'D002189', 'term': 'Marijuana Abuse'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004329', 'term': 'Droperidol'}, {'id': 'D004155', 'term': 'Diphenhydramine'}], 'ancestors': [{'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-18', 'studyFirstSubmitDate': '2022-02-07', 'studyFirstSubmitQcDate': '2022-02-16', 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in symptoms after treatment with droperidol and diphenhydramine', 'timeFrame': 'Baseline, 30 minutes, 60 minutes and 120 minutes. Then at 24 hours and 48 hours.', 'description': '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)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cannabis Hyperemesis Syndrome']}, 'referencesModule': {'references': [{'pmid': '33160719', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30729854', 'type': 'BACKGROUND', 'citation': 'Lee 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.'}, {'pmid': '23583118', 'type': 'BACKGROUND', 'citation': 'Hickey 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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of droperidol as a treatment of cannabinoid hyperemesis syndrome.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 years of age or older and presenting with cannabis hyperemesis syndrome requiring intravenous medication.\n\nExclusion Criteria:\n\n* any patient with a contraindication to the use of droperidol\n* Corrected QT interval on ECG greater than 440 milliseconds for males and greater than 450 milliseconds for females\n* any prisoners\n* pregnant females.'}, 'identificationModule': {'nctId': 'NCT05244460', 'acronym': 'DOPE', 'briefTitle': 'Droperidol on Prevention of Cannabis Hyperemesis Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Mercy Health Ohio'}, 'officialTitle': 'Droperidol on Prevention of Emesis From Cannabinoid Hyperemesis Syndrome', 'orgStudyIdInfo': {'id': '21-029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Patients who receive droperidol 2.5mg intravenous once and diphenhydramine 25mg intravenous once', 'interventionNames': ['Drug: Droperidol Injectable Product', 'Drug: Diphenhydramine']}], 'interventions': [{'name': 'Droperidol Injectable Product', 'type': 'DRUG', 'otherNames': ['Inapsine'], 'description': 'Treatment', 'armGroupLabels': ['Intervention']}, {'name': 'Diphenhydramine', 'type': 'DRUG', 'otherNames': ['Benadryl'], 'description': 'Treatment', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44515', 'city': 'Austintown', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benjamin Pugsley, DO', 'role': 'CONTACT', 'email': 'bpugsley1@mercy.com', 'phone': '619-972-5453'}], 'facility': 'Mercy Health - Austintown', 'geoPoint': {'lat': 41.10172, 'lon': -80.76452}}, {'zip': '44512', 'city': 'Boardman', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joseph Noga, DO', 'role': 'CONTACT', 'email': 'jnoga@mercy.com', 'phone': '724-944-7500'}], 'facility': 'St Elizabeth Boardman Hospital', 'geoPoint': {'lat': 41.02423, 'lon': -80.66285}}, {'zip': '44484', 'city': 'Warren', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benjamin Pugsley, DO', 'role': 'CONTACT', 'email': 'bpugsley1@mercy.com', 'phone': '619-972-5453'}], 'facility': 'St. Joseph-Warren Hospital', 'geoPoint': {'lat': 41.23756, 'lon': -80.81842}}, {'zip': '44501', 'city': 'Youngstown', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chad Donley, MD', 'role': 'CONTACT', 'email': 'chad_donley1@mercy.com', 'phone': '330-729-7960'}], 'facility': 'St Elizabeth Youngstown Hospital', 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}], 'centralContacts': [{'name': 'Todd Bolotin, MD', 'role': 'CONTACT', 'email': 'tbolotin@mercy.com', 'phone': '3302193838'}, {'name': 'Quincy Chopra, MD', 'role': 'CONTACT', 'email': 'qchopra@mercy.com', 'phone': '4128059742'}], 'overallOfficials': [{'name': 'Todd Bolotin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mercy Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mercy Health Ohio', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lake Erie College of Osteopathic Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}