Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-02-28 @ 2:50 AM
Study NCT ID:
NCT01400204
Status:
COMPLETED
Last Update Posted:
2011-07-22
First Post:
2011-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Naturalistic Study Into the Hangover Effects of MDMA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-21', 'studyFirstSubmitDate': '2011-07-21', 'studyFirstSubmitQcDate': '2011-07-21', 'lastUpdatePostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hangover', 'next day effects', 'MDMA', 'Alcohol'], 'conditions': ['Hangover']}, 'descriptionModule': {'briefSummary': "The aim of the study is to compare hangover effects of MDMA users versus those who used other drugs, or alcohol only at New Year's Eve. The week after New Years Eve, every day participants complete a questionnaire about the presence and severity of potential hangover symptoms. At day 1, demographics and alcohol and drug use at New Years Eve were recorded. On day 7, the Brief Symptom Inventory (BSI) is completed to asses last weeks mood. After 4 weeks, after a drug-free week, the BSI is completed again to serve as a reference.", 'detailedDescription': 'A convenience sample was invited by e-mail to participate in the study, via the organizer of a private New Years Party.It was attempted to include as much participants as possible. Hence, no sampling method was applied when recruiting participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Recreational poly-drug users who were guests at a privat New Years Eve party', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* poly drug user\n* 18+ years old\n\nExclusion Criteria:\n\n* mental or physical illness'}, 'identificationModule': {'nctId': 'NCT01400204', 'briefTitle': 'Naturalistic Study Into the Hangover Effects of MDMA', 'organization': {'class': 'OTHER', 'fullName': 'Utrecht Institute for Pharmaceutical Sciences'}, 'officialTitle': 'A Naturalistic Study Comparing the Hangover Effects of MDMA, Other Drugs, and Alcohol in a Sample of Recreational Polydrug Users', 'orgStudyIdInfo': {'id': 'ppo-010-212'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MDMA', 'description': 'poly drug users that used MDMA at New Years Eve'}, {'label': 'Other Drugs', 'description': 'poly drug users that used drugs at New Years Eve, but not MDMA'}, {'label': 'Alcohol', 'description': 'poly drug users that used no drugs at New Years Eve, but did consume alcohol'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3584CG', 'city': 'Utrecht', 'state': 'Utrecht', 'country': 'Netherlands', 'facility': 'Utrecht University', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Joris C Verster, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Utrecht University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Utrecht Institute for Pharmaceutical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Joris C Verster, PhD', 'oldOrganization': 'Utrecht University'}}}}