Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-03-01 @ 6:10 AM
Study NCT ID:
NCT01780805
Status:
COMPLETED
Last Update Posted:
2020-03-06
First Post:
2013-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Second Young Adult Naturalistic Alcohol Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2013-01-24', 'studyFirstSubmitQcDate': '2013-01-28', 'lastUpdatePostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Self-reported drinks per drinking day', 'timeFrame': '6- and 12-month follow-ups after alcohol drinking session'}, {'measure': 'Self-reported frequency of heavy drinking days', 'timeFrame': '6- and 12-month follow-up after alcohol drinking session'}], 'primaryOutcomes': [{'measure': 'Peak estimated blood alcohol concentration', 'timeFrame': 'During a 3-hour alcohol drinking period'}], 'secondaryOutcomes': [{'measure': 'Number of alcoholic drinks consumed', 'timeFrame': 'During a 3-hour alcohol drinking period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Young Adult Alcohol Drinking']}, 'descriptionModule': {'briefSummary': 'This study involves completion of questionnaires, computer-based cognitive tasks and an alcohol drinking session. Participation in this study consists of an initial, in-person screening appointment, 4 brief daily appointments at the research office, an alcohol drinking session at a local bar and a follow-up appointment 1-3 days after the alcohol drinking session.\n\nParticipants who are found to be eligible in the screening phase will then complete a daily appointment for 4 days out of a 5-day period (i.e., there will be 1 day out of the 5 on which they will not attend an appointment). Each appointment will last 20 minutes, on average and consist of a questionnaire and computer-based cognitive task. On the day of the fourth appointment, participants will complete an alcohol drinking session. The alcohol drinking session begins at 4pm and lasts until at least midnight.\n\nParticipants in this study will be young adults between the ages of 21-25, who regularly drink alcohol and are not currently seeking treatment for alcohol use. Seventy-two participants will complete this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy young adults between the ages of 21-25 years of ago who regularly drink alcohol and are not currently seeking treatment for alcohol.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be between the ages of 21-25.\n* Be able to read English and complete study evaluations.\n* Drink alcohol on a regular basis\n\nExclusion Criteria:\n\nNo participant may:\n\n* Be seeking treatment for alcohol or other addictive behaviors or have been in inpatient or intensive outpatient treatment within the past 12 months.\n* Provide two positive breath alcohol concentration (BAC) readings (i.e., \\> 0.00%) at any of the following times: in-person screening, a pre-session screening, or at the outset of an alcohol self-administration session. After participants blow their first positive BAC, they will be allowed to reschedule and participate at another time, however if they blow a second positive BAC, they will be excluded from this study and offered referrals for alcohol treatment.\n* Have positive urine screen results at the in-person screening or pre-session screening on the day of an alcohol self-administration session for opiates, cocaine, phencyclidine, amphetamines, methamphetamine, barbiturates, methadone or benzodiazepines.\n* A woman who is pregnant, nursing, or refuses to use a reliable method of birth control.\n* Fail to perform at a normative level at screening on any of the four cognitive and psychomotor tasks administered in this study. Participants must perform within two standard deviations of the mean from the samples in relevant prior studies\n* Perform computer tasks initially administered at baseline in either a random or inordinately slow fashion\n* A body mass index lower than 18.5 or greater than 35.'}, 'identificationModule': {'nctId': 'NCT01780805', 'acronym': 'YANAS-2', 'briefTitle': 'Second Young Adult Naturalistic Alcohol Study', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Second Young Adult Naturalistic Alcohol Study (YANAS-2)', 'orgStudyIdInfo': {'id': '1209010754'}, 'secondaryIdInfos': [{'id': 'R03AA022232', 'link': 'https://reporter.nih.gov/quickSearch/R03AA022232', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Young adult alcohol drinkers', 'description': 'Young adults between the ages of 21-25 who regularly drink alcohol'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Robert F Leeman, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}