Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-28 @ 10:59 AM
Study NCT ID:
NCT01798303
Status:
COMPLETED
Last Update Posted:
2017-02-03
First Post:
2013-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY2940094 in Participants With Alcohol Dependency
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625550', 'term': 'LY2940094'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'dispFirstSubmitDate': '2014-09-29', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-01', 'studyFirstSubmitDate': '2013-02-21', 'dispFirstSubmitQcDate': '2014-09-29', 'studyFirstSubmitQcDate': '2013-02-21', 'dispFirstPostDateStruct': {'date': '2014-10-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline to Week 8 in the Average Number of Drinks per Day (NDD) Measured Over 28 Days', 'timeFrame': 'Baseline, Week 8'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline to Week 8 in Gammaglutamyl Transferase (GGT)', 'timeFrame': 'Baseline, Week 8'}, {'measure': 'Percentage of Heavy Drinking Days per Month', 'timeFrame': 'Baseline and Week 8'}, {'measure': 'Percentage of Days Abstinent per Month', 'timeFrame': 'Baseline and Week 8'}, {'measure': 'Percentage of Participants with No (0) Heavy Drinking Days per Month', 'timeFrame': 'Baseline and Week 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alcoholism']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate a once daily (QD) 40-milligram (mg) oral dose of LY2940094 in participants with an alcohol dependency to evaluate if LY2940094 will reduce alcohol drinking in these participants. The study will last for 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Present with alcohol dependence (AD) defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR 303.9)\n* Must have 3 to 6 heavy drinking days per week as assessed by the Timeline Follow Back (TLFB) scale at screening and baseline (heavy drinking is defined as greater than 4 drinks per day for females and greater than 5 drinks per day for males)\n* Have a body mass index (BMI) between 18 and 35 kilograms per square meter (kg/m\\^2)\n\nExclusion Criteria:\n\n* Have had prior seizures or other condition that would place the participant at increased risk of seizures, and participants taking anticonvulsants for seizure control\n* Have any other clinically significant medical condition or circumstance prior to randomization that, in the opinion of the investigator, could affect participant safety\n* Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, (DSM-IV) Axis I criteria for a lifetime diagnosis of schizophrenia, schizoaffective disorder, bipolar I disorder, or other psychoses'}, 'identificationModule': {'nctId': 'NCT01798303', 'briefTitle': 'A Study of LY2940094 in Participants With Alcohol Dependency', 'organization': {'class': 'INDUSTRY', 'fullName': 'BlackThorn Therapeutics, Inc.'}, 'officialTitle': 'Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial in Patients With Alcohol Dependence', 'orgStudyIdInfo': {'id': '14792'}, 'secondaryIdInfos': [{'id': 'I5J-MC-NOAD', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY2940094', 'description': '40 mg LY2940094 oral tablet, QD for 8 weeks', 'interventionNames': ['Drug: LY2940094']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Identically matched placebo oral tablet, QD for 8 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY2940094', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY2940094']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BlackThorn Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}