Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-24 @ 3:49 PM
Study NCT ID:
NCT04283292
Status:
COMPLETED
Last Update Posted:
2024-10-18
First Post:
2020-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Capsaicin for the Treatment of Cannabinoid 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': 'D002211', 'term': 'Capsaicin'}], 'ancestors': [{'id': 'D053284', 'term': 'Polyunsaturated Alkamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'investigational pharmacists and designated personell will the only unblinded study staff.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized to capsaicin or placebo in a 1:1 ratio (like the flip of a coin).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2020-02-21', 'studyFirstSubmitQcDate': '2020-02-24', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Symptom improvement at thirty days', 'timeFrame': '30 days (outpatient phone call)', 'description': 'Follow-up phone call at thirty days to investigate any symptom improvement or change in cannabinoid usage.'}], 'primaryOutcomes': [{'measure': 'Time to resolution of symptoms', 'timeFrame': '1 day (During emergency department admission)', 'description': 'Time that it takes for symptoms to be resolved for those with Cannabinoid Hyperemesis Syndrome'}], 'secondaryOutcomes': [{'measure': 'Clinical improvement in pain score', 'timeFrame': '1 day (During emergency department admission)', 'description': 'Clinical improvement in pain score as defined by visual analog score with a scale from 0-10 where is 0 is no pain and 10 is unbearable pain. Pain should decrease over time and this will be measure by the visual analog scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cannabinoid Hyperemesis Syndrome']}, 'descriptionModule': {'briefSummary': 'This study aims to determine if capsaicin cream offers symptomatic relief to patients suffering from Cannabinoid Hyperemesis Syndrome (condition that leads to repeated and severe bouts of vomiting).', 'detailedDescription': 'Objectives:\n\nThe purpose of this study is to determine if capsaicin cream offers symptomatic relief to patients suffering from Cannabinoid Hyperemesis Syndrome. We hypothesize that the use of topical capsaicin may provide effective symptomatic relief more quickly than conventional anti-emetic therapy alone thereby decreasing costs for continued drug therapies, repeat laboratory testing, radiographic imaging, and specialist consults.\n\nPrimary endpoint:\n\nTime to resolution of symptoms, clinical improvement in pain score as defined by visual analog score.\n\nApproach and methods:\n\nPatients presenting to the UVA Emergency Department with chief complaint of nausea and vomiting who endorse cannabinoid use via inhalation or consumption. Patients 18 years of age and older will be included in the study and patients who have another clear indication for nausea/vomiting or cyclic vomiting (infection, appendicitis, pain, etc.) will be excluded. Patients who are enrolled in the study will be randomized 1:1 to treatment vs. placebo. All patients will be allowed 1L of intravenous fluids and one to two standard anti-emetics. The Investigational Drug Services team at UVA will be involved in compounding the capsaicin treatment versus placebo and drug/placebo shall remain in place for at least 30 minutes. Clinical improvement will be scored based on visual analog score for pain and assessment at hourly increments until discharge or admission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years old\n* Diagnosis of cannabinoid hyperemesis syndrome\n\nExclusion Criteria:\n\n* Patients who receive more than 2 anti-emetic therapies prior to screening for enrollment\n* Patients who receive haloperidol as an anti-emetic therapy\n* Pregnant women\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT04283292', 'briefTitle': 'Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome', 'orgStudyIdInfo': {'id': '21957'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Capsaicin', 'description': 'capsaicin 0.075% cream applied once topically', 'interventionNames': ['Drug: Capsaicin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': 'placebo cream applied once topically', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Capsaicin', 'type': 'DRUG', 'otherNames': ['Zostrix'], 'description': 'Topical Capsaicin for the treatment of Cannabinoid Hyperemesis Syndrome', 'armGroupLabels': ['Capsaicin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo cream that is applied once topically', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'UVA Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Angela Holian, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Emergency Medicine Clinical Pharmacist', 'investigatorFullName': 'Angela Holian', 'investigatorAffiliation': 'University of Virginia'}}}}