Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-03-16 @ 9:45 PM
Study NCT ID:
NCT01063166
Status:
COMPLETED
Last Update Posted:
2016-01-21
First Post:
2010-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Assessment of Adolescent Drinking Trajectories With Computer-Assisted Self-administration of Ethanol (CASE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-20', 'studyFirstSubmitDate': '2010-02-04', 'studyFirstSubmitQcDate': '2010-02-04', 'lastUpdatePostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol consumption', 'timeFrame': '2 years', 'description': 'Alcohol consumption, as measured by a Timeline Followback Interview and experimental Self-Administration.'}], 'secondaryOutcomes': [{'measure': 'Alcohol Use Disorders', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alcoholism']}, 'referencesModule': {'references': [{'pmid': '32584051', 'type': 'DERIVED', 'citation': "Obst E, Bernhardt N, Gan G, Plawecki MH, O'Connor S, Smolka MN, Zimmermann US. Sensation seeking, impulsivity, and aggression moderate sex effects on adolescent laboratory binging. Psychol Addict Behav. 2021 Mar;35(2):208-214. doi: 10.1037/adb0000651. Epub 2020 Jun 25."}]}, 'descriptionModule': {'briefSummary': 'The Computer-Assisted Self-administration of Ethanol (CASE)will be administered twice, at the ages 18 and 20, in a prospective study of 80 adolescents living in the Dresden area. The sample will be recruited for a differential family history of alcoholism (FHA) and gender, with inventories of alcohol use disorder (AUD) symptoms and personal recent drinking history (RDH) obtained prior to each CASE session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '19 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Residents living within 15 km (9.5 miles) from downtown Dresden', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (a) male and female Caucasian volunteers aged 18 years/0 months to 19 years/11 months;\n* (b) written informed consent by the subject;\n* (c) habitual social drinking during the two months preceding participation, defined by at least one drinking day in any two weeks-interval;\n* (d) at least one prior experience of alcohol intoxication\n* (e) being able to abstain from tobacco use for four hours without developing nicotine withdrawal symptoms;\n* (f) effective contraception in female participants;\n* (g) consenting to abstain from any illegal substance use for 2 weeks prior to participation;\n* (h) living within 15 km (9.5 miles) from downtown Dresden;\n* (i) sufficient information concerning alcohol use in both parents and in at least four second-degree relatives\n\nExclusion Criteria:\n\n* (a) prior medical treatment due to alcohol use;\n* (b) current or prior history of any serious disease, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, alcohol or drug dependence, but not alcohol abuse;\n* (c) current history of Axis-I psychiatric illness, including premenstrual dysphoric disorder;\n* (d) current or prior history of alcohol-induced flushing reactions;\n* (e) positive urine screen for cannabinoids, cocaine, amphetamines, opiates, or benzodiazepines;\n* (f) light or non-drinkers: averaging less than 2 standard drinks per week in the preceding two months;\n* (g) intention to become pregnant\n* (h) pregnancy or positive urine pregnancy screening or breast-feeding;\n* (i) any alcohol intake on the test day or the day before;\n* (k) use of medications known to interact with alcohol within 2 weeks of the study;\n* (l) positive hepatitis or HIV at screening, provided the subject consented to these tests'}, 'identificationModule': {'nctId': 'NCT01063166', 'briefTitle': 'Prospective Assessment of Adolescent Drinking Trajectories With Computer-Assisted Self-administration of Ethanol (CASE)', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Collaboration on Alcohol Self Administration in Adolescents and Young Adults - Specific Aim 1: Assess the Initial Slope of Adolescent Drinking Trajectories, Beginning at the Age of Eighteen', 'orgStudyIdInfo': {'id': 'U01 AA017900 SA1'}, 'secondaryIdInfos': [{'id': 'U01AA017900', 'link': 'https://reporter.nih.gov/quickSearch/U01AA017900', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Ulrich S Zimmermann, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'collaborators': [{'name': 'Indiana University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}