Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT03594435
Status:
COMPLETED
Last Update Posted:
2024-11-27
First Post:
2018-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Ibudilast for the Treatment of Alcohol Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}}}}, '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': 'C038366', 'term': 'ibudilast'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lararay@psych.ucla.edu', 'phone': '310-206-6756', 'title': 'Dr. Lara Ray', 'organization': 'University of California Los Angeles'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for each participant between randomization to Week 12 visit (final day of study).', 'description': 'The study physician (Dr. Miotto) called every participant at the end of the first week on the study medication to discuss any adverse events. Adverse events were also collected at each monthly visit and the study physician was notified of any reported adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Ibudilast', 'description': '10mg delayed-release capsules, target dose 50mg twice daily (5 x 10mg capsules twice daily) for 12 weeks\n\nIbudilast: targets neurotrophin signaling and neuroimmune function', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 36, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo Oral Capsule', 'description': 'matched to experimental drug\n\nPlacebo oral capsule: matched to active drug, ibudilast', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 27, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Body pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Libido', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gut pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin discoloration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysmenorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal EKG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurry vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain and discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Left Upper Quadrant Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left Ankle Open Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subdural Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Heavy Drinking Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibudilast', 'description': '10mg delayed-release capsules, target dose 50mg twice daily (5 x 10mg capsules twice daily) for 12 weeks\n\nibudilast: targets neurotrophin signaling and neuroimmune function'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'matched to experimental drug\n\nPlacebo oral capsule: matched to active drug, ibudilast'}], 'classes': [{'title': 'Randomization', 'categories': [{'measurements': [{'value': '67.4777', 'spread': '34.54664', 'groupId': 'OG000'}, {'value': '65.65447', 'spread': '34.89305', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 Follow-up', 'categories': [{'measurements': [{'value': '53.88376', 'spread': '38.62032', 'groupId': 'OG000'}, {'value': '42.96028', 'spread': '42.12516', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Follow-up', 'categories': [{'measurements': [{'value': '48.57848', 'spread': '40.24403', 'groupId': 'OG000'}, {'value': '43.54836', 'spread': '42.40074', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 Follow-up', 'categories': [{'measurements': [{'value': '40.13970', 'spread': '41.51441', 'groupId': 'OG000'}, {'value': '45.83959', 'spread': '39.41569', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 Follow-up', 'categories': [{'measurements': [{'value': '47.88029', 'spread': '40.47520', 'groupId': 'OG000'}, {'value': '35.80680', 'spread': '40.36051', 'groupId': 'OG001'}]}]}, {'title': 'Week 10 Follow-up', 'categories': [{'measurements': [{'value': '43.36704', 'spread': '40.82088', 'groupId': 'OG000'}, {'value': '37.54797', 'spread': '40.80282', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 Follow-up', 'categories': [{'measurements': [{'value': '34.96705', 'spread': '38.75223', 'groupId': 'OG000'}, {'value': '35.33841', 'spread': '40.07343', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 week-treatment period', 'description': 'Heavy drinking days defined as 5+ drinks for men and 4+ for women. Reported outcome measures are proportions of heavy drinking days.', 'unitOfMeasure': 'percent of heavy drinking days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Drinks Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibudilast', 'description': '10mg delayed-release capsules, target dose 50mg twice daily (5x 10mg capsules twice daily) for 12 weeks\n\nibudilast: targets neurotrophin signaling and neuroimmune function'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'matched to experimental drug\n\nPlacebo oral capsule: matched to active drug, ibudilast'}], 'classes': [{'title': 'Randomization', 'categories': [{'measurements': [{'value': '5.5569643', 'spread': '3.8825400', 'groupId': 'OG000'}, {'value': '5.0916392', 'spread': '3.2844504', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 Follow-up', 'categories': [{'measurements': [{'value': '2.9712639', 'spread': '2.6163298', 'groupId': 'OG000'}, {'value': '2.5307298', 'spread': '2.5759514', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Follow-up', 'categories': [{'measurements': [{'value': '2.9416414', 'spread': '3.0687885', 'groupId': 'OG000'}, {'value': '2.7376672', 'spread': '2.2163207', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 Follow-up', 'categories': [{'measurements': [{'value': '2.9004471', 'spread': '3.1327782', 'groupId': 'OG000'}, {'value': '2.4886257', 'spread': '1.9787647', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 Follow-up', 'categories': [{'measurements': [{'value': '2.5295239', 'spread': '2.0967361', 'groupId': 'OG000'}, {'value': '1.9764896', 'spread': '2.0375665', 'groupId': 'OG001'}]}]}, {'title': 'Week 10 Follow-up', 'categories': [{'measurements': [{'value': '2.3335342', 'spread': '2.2920357', 'groupId': 'OG000'}, {'value': '1.9942146', 'spread': '1.9999379', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 Follow-up', 'categories': [{'measurements': [{'value': '2.2639331', 'spread': '2.2143404', 'groupId': 'OG000'}, {'value': '1.9131006', 'spread': '2.0874590', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12-week treatment period', 'description': 'Secondary alcohol consumption endpoint. Outcome measure reported is the proportion of drinks per day. Drinks per day across the trial. Randomization is the first day of study intervention after study eligibility was determined.', 'unitOfMeasure': 'Drinking per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Drinks Per Drinking Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibudilast', 'description': '10mg delayed-release capsules, target dose 50mg twice daily (5x 10mg capsules twice daily) for 12 weeks\n\nibudilast: targets neurotrophin signaling and neuroimmune function'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'matched to experimental drug\n\nPlacebo oral capsule: matched to active drug, ibudilast'}], 'classes': [{'title': 'Randomization', 'categories': [{'measurements': [{'value': '7.5702563', 'spread': '4.3026834', 'groupId': 'OG000'}, {'value': '7.5157381', 'spread': '6.3591036', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 Follow-up', 'categories': [{'measurements': [{'value': '6.0380129', 'spread': '4.2269696', 'groupId': 'OG000'}, {'value': '4.6825232', 'spread': '3.6986878', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Follow-up', 'categories': [{'measurements': [{'value': '5.1232947', 'spread': '3.6194523', 'groupId': 'OG000'}, {'value': '4.8648040', 'spread': '4.2417622', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 Follow-up', 'categories': [{'measurements': [{'value': '4.8955457', 'spread': '3.9859161', 'groupId': 'OG000'}, {'value': '4.4555121', 'spread': '3.1474673', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 Follow-up', 'categories': [{'measurements': [{'value': '4.9961214', 'spread': '3.4733168', 'groupId': 'OG000'}, {'value': '3.4954873', 'spread': '2.7084074', 'groupId': 'OG001'}]}]}, {'title': 'Week 10 Follow-up', 'categories': [{'measurements': [{'value': '4.6825531', 'spread': '4.1278832', 'groupId': 'OG000'}, {'value': '3.3946192', 'spread': '2.5414040', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 Follow-up', 'categories': [{'measurements': [{'value': '4.1250715', 'spread': '3.1777328', 'groupId': 'OG000'}, {'value': '3.4113607', 'spread': '2.4958175', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12-week treatment period', 'description': 'Secondary alcohol consumption endpoint. Drinks per drinking day is defined as how many drinks an individual consumed on a day they reported drinking alcohol.', 'unitOfMeasure': 'drinks per drinking day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Days Abstinent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibudilast', 'description': '10mg delayed-release capsules, target dose 50mg twice daily (5x 10mg capsules twice daily) for 12 weeks\n\nibudilast: targets neurotrophin signaling and neuroimmune function'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'matched to experimental drug\n\nPlacebo oral capsule: matched to active drug, ibudilast'}], 'classes': [{'title': 'Randomization', 'categories': [{'measurements': [{'value': '25.28269', 'spread': '24.86230', 'groupId': 'OG000'}, {'value': '24.28538', 'spread': '24.71130', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 Follow-up', 'categories': [{'measurements': [{'value': '52.10013', 'spread': '31.53534', 'groupId': 'OG000'}, {'value': '51.24152', 'spread': '36.33756', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Follow-up', 'categories': [{'measurements': [{'value': '53.49783', 'spread': '33.79115', 'groupId': 'OG000'}, {'value': '46.76799', 'spread': '35.31845', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 Follow-up', 'categories': [{'measurements': [{'value': '50.14506', 'spread': '34.61062', 'groupId': 'OG000'}, {'value': '49.30242', 'spread': '36.06276', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 Follow-up', 'categories': [{'measurements': [{'value': '49.85351', 'spread': '35.34000', 'groupId': 'OG000'}, {'value': '54.99929', 'spread': '38.86134', 'groupId': 'OG001'}]}]}, {'title': 'Week 10 Follow-up', 'categories': [{'measurements': [{'value': '56.10048', 'spread': '34.49246', 'groupId': 'OG000'}, {'value': '54.35469', 'spread': '37.55533', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 Follow-up', 'categories': [{'measurements': [{'value': '54.86251', 'spread': '34.42088', 'groupId': 'OG000'}, {'value': '55.35643', 'spread': '38.60974', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12-week treatment period', 'description': 'Secondary alcohol consumption endpoint. Outcome measure reported is the proportion of percent days abstinent.', 'unitOfMeasure': 'percent days abstinent.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ibudilast', 'description': '10mg delayed-release capsules, target dose 50mg twice daily (5 x 10mg capsules twice daily) for 12 weeks\n\nibudilast: targets neurotrophine signaling and neuroimmune function'}, {'id': 'FG001', 'title': 'Placebo Oral Capsule', 'description': 'matched to experimental drug\n\nPlacebo oral capsule: matched to active drug, ibudilast'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Participants were recruited via online and print advertisements, local bus campaigns, and targeted recruitment through a laboratory database of previous study participants who agreed to be contacted for further studies.', 'preAssignmentDetails': 'A stratified randomization list was developed by a statistician and was based on gender, drinking status (moderate drinking defined as ≥ 14 drinks/week for men and ≥ 7 drinks/week for women versus heavy drinking defined as ≥ 28 drinks/week for men and ≥ 21 drinks/week for women).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ibudilast', 'description': '10mg delayed-release capsules, target dose 50mg twice daily (5 x 10mg capsules twice daily) for 12 weeks.\n\nibudilast: targets neurotrophin signaling and neuroimmune function'}, {'id': 'BG001', 'title': 'Placebo Oral Capsule', 'description': 'matched to experimental drug\n\nPlacebo oral capsule: matched to active drug, ibudilast'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.74', 'spread': '10.01', 'groupId': 'BG000'}, {'value': '45.92', 'spread': '11.49', 'groupId': 'BG001'}, {'value': '44.26', 'spread': '10.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Drinks per drinking day', 'classes': [{'categories': [{'measurements': [{'value': '7.57', 'spread': '4.30', 'groupId': 'BG000'}, {'value': '7.52', 'spread': '3.36', 'groupId': 'BG001'}, {'value': '7.54', 'spread': '5.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Drinks per drinking day at baseline was measured using the timeline followback. This measure is defined as the number of drinks a participant had on a reported day of drinking during the 30-day prior to the baseline visit.', 'unitOfMeasure': 'drinks per drinking day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percent heavy drinking days', 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'spread': '34.55', 'groupId': 'BG000'}, {'value': '65.7', 'spread': '34.89', 'groupId': 'BG001'}, {'value': '66.6', 'spread': '34.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent heavy drinking days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of drinking days', 'classes': [{'categories': [{'measurements': [{'value': '22.42', 'spread': '7.46', 'groupId': 'BG000'}, {'value': '22.71', 'spread': '7.41', 'groupId': 'BG001'}, {'value': '22.56', 'spread': '7.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'drinking days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Positive THC screen', 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mild Cannabis Use Disorder', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Any cigarette use', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Any cigarette use as indexed by any reported cigarette use on the past 30-day timeline followback.', 'unitOfMeasure': 'Participants'}, {'title': 'Smokes cigarettes', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Smokes cigarettes was measured using item 1 of the Fagerstrom Test for Nicotine Dependence ('How often do you smoke (cigarettes)?'). Participants who marked daily or occasionally were identified as participants who smoke cigarettes and those who marked not at all were identified as participants who do not smoke cigarettes.", 'unitOfMeasure': 'Participants'}, {'title': 'Penn Alcohol Craving Scale Total', 'classes': [{'categories': [{'measurements': [{'value': '13.83', 'spread': '5.85', 'groupId': 'BG000'}, {'value': '13.73', 'spread': '6.56', 'groupId': 'BG001'}, {'value': '13.78', 'spread': '6.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Penn Alcohol Craving Scale (PACS) measures alcohol craving. The total score ranges from 0 to 30 with higher scores indicating more alcohol craving.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Structured Clinical Interview Alcohol Use Disorder symptom count', 'classes': [{'categories': [{'measurements': [{'value': '7.15', 'spread': '2.05', 'groupId': 'BG000'}, {'value': '6.27', 'spread': '1.69', 'groupId': 'BG001'}, {'value': '6.73', 'spread': '1.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Structured Clinical Interview of Alcohol Use Disorder (AUD) symptom count measures the number of AUD symptoms participants endorse. Symptom count ranges from 0 to 11, with 0-1 symptoms indicating no alcohol disorder, 2-3 symptoms indicating mild alcohol use disorder, 4-5 symptoms indicating moderate alcohol use disorder, and 6 or more symptoms indicating severe alcohol use disorder.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alcohol Use Disorders Identification Test', 'classes': [{'categories': [{'measurements': [{'value': '21.23', 'spread': '8.24', 'groupId': 'BG000'}, {'value': '19.16', 'spread': '6.14', 'groupId': 'BG001'}, {'value': '20.24', 'spread': '7.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Alcohol Use Disorder Identification Test (AUDIT) identifies individuals with hazardous and harmful patterns of alcohol consumption. Total scores range from 0 to 40. A score of 1-7 indicates low risk consumption, scores 8-14 indicate hazardous or harmful alcohol consumption, and 15 or more indicates likelihood of alcohol dependence.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Relief/Habit Drinking', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current Depression', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Beck's Depression Inventory-II Total", 'classes': [{'categories': [{'measurements': [{'value': '11.98', 'spread': '8.55', 'groupId': 'BG000'}, {'value': '10.73', 'spread': '7.13', 'groupId': 'BG001'}, {'value': '11.38', 'spread': '7.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Beck's Depression Inventory-II (BDI-II) captures depressive symptomatology. Total scores range from 0 to 63. Scores between 0-9 indicates minimal depression, 10-18 indicates mild depression, 19-29 indicates moderate depression, and 30-63 indicates severe depression.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Beck's Anxiety Inventory Total", 'classes': [{'categories': [{'measurements': [{'value': '8.53', 'spread': '7.87', 'groupId': 'BG000'}, {'value': '6.94', 'spread': '7.08', 'groupId': 'BG001'}, {'value': '7.76', 'spread': '7.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Beck's Anxiety Inventory (BAI) measures anxiety symptomatology including physical and cognitive indicators of anxious mood. Total scores range from 0 to 63. A score between 0-7 indicates minimal anxiety, 8-15 indicates mild anxiety, 16-25 indicates moderate anxiety, and 26-63 indicates severe anxiety.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insomnia Severity Index Total', 'classes': [{'categories': [{'measurements': [{'value': '9', 'spread': '6.29', 'groupId': 'BG000'}, {'value': '7.98', 'spread': '5.23', 'groupId': 'BG001'}, {'value': '8.51', 'spread': '5.80', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Insomnia Severity Index (ISI) assess symptoms of insomnia. Total scores range from 0-28. Scores between 0-7 indicate no clinical significant insomnia, 8-14 indicates sub-threshold insomnia, 15-21 indicates clinical insomnia (moderately severity), and 22-28 indicates clinical insomnia (severe).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-01', 'size': 686084, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-12T17:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-Arm, Randomized, Double-Blind, Placebo-Controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'dispFirstSubmitDate': '2024-04-10', 'completionDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-03', 'studyFirstSubmitDate': '2018-07-11', 'resultsFirstSubmitDate': '2024-07-12', 'studyFirstSubmitQcDate': '2018-07-11', 'dispFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-03', 'studyFirstPostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Heavy Drinking Days', 'timeFrame': '12 week-treatment period', 'description': 'Heavy drinking days defined as 5+ drinks for men and 4+ for women. Reported outcome measures are proportions of heavy drinking days.'}], 'secondaryOutcomes': [{'measure': 'Drinks Per Day', 'timeFrame': '12-week treatment period', 'description': 'Secondary alcohol consumption endpoint. Outcome measure reported is the proportion of drinks per day. Drinks per day across the trial. Randomization is the first day of study intervention after study eligibility was determined.'}, {'measure': 'Drinks Per Drinking Day', 'timeFrame': '12-week treatment period', 'description': 'Secondary alcohol consumption endpoint. Drinks per drinking day is defined as how many drinks an individual consumed on a day they reported drinking alcohol.'}, {'measure': 'Percent Days Abstinent', 'timeFrame': '12-week treatment period', 'description': 'Secondary alcohol consumption endpoint. Outcome measure reported is the proportion of percent days abstinent.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ibudilast, treatment, medication development'], 'conditions': ['Alcohol Use Disorder']}, 'referencesModule': {'references': [{'pmid': '40305022', 'type': 'DERIVED', 'citation': 'Ray LA, Meredith LR, Grodin EN, Belnap MA, Nieto SJ, Baskerville WA, Donato S, Shoptaw SJ, Gillis AJ, Irwin MR, Miotto K, Enders CK. A Neuroimmune Modulator for Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e257523. doi: 10.1001/jamanetworkopen.2025.7523.'}, {'pmid': '32912290', 'type': 'DERIVED', 'citation': 'Burnette EM, Baskerville WA, Grodin EN, Ray LA. Ibudilast for alcohol use disorder: study protocol for a phase II randomized clinical trial. Trials. 2020 Sep 11;21(1):779. doi: 10.1186/s13063-020-04670-y.'}]}, 'descriptionModule': {'briefSummary': 'This study is a double-blind, placebo-controlled randomized clinical trial of Ibudilast (IBUD) (50mg twice a day) for the treatment of Alcohol Use Disorder (AUD). Eligible participants will undergo a 12-week medication treatment period and 5 in-person visits over 16 weeks.', 'detailedDescription': 'The study design consists of a 12-week, double-blind, placebo-controlled randomized clinical trial of IBUD (50mg twice a day) for the treatment of AUD. The investigators will randomize 132 treatment-seekers with current AUD over the course of 4 years. Participants will complete telephone screening, followed by in-person eligibility assessment, a physical exam for medical eligibility, randomization to study medication or matched placebo, and in-person follow-up visits at 4, 8, and 12 weeks of treatment. Timeline Followback (TLFB) assessment of drinking outcomes will also occur by telephone on weeks 2, 6, and 10. A final safety check visit will occur on week 16, consisting of repeated clinical labs and electrocardiography (ECG).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be between the ages of 18 and 65\n2. Meet current (i.e., past 12 months) Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for alcohol use disorder moderate or severe\n3. Be treatment-seeking for alcohol use disorder (AUD)\n4. Report drinking at least 28 drinks per week if male (21 drinks per week if female) in the 28 days prior to consent\n\nExclusion Criteria:\n\n1. Have a current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine\n2. Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder\n3. Have a positive urine screen for narcotics, amphetamines, or sedative hypnotics;\n4. Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R)\n5. Be pregnant, nursing, or planning to become pregnant while taking part in the study; and must agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile:\n\n * Oral contraceptives\n * Contraceptive sponge\n * Patch\n * Double barrier\n * Intrauterine contraceptive device\n * Etonogestrel implant\n * Medroxyprogesterone acetate contraceptive injection\n * Complete abstinence from sexual intercourse\n * Hormonal vaginal contraceptive ring\n6. Have a medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes)\n7. Have aspartate aminotransferase (AST), alanine transaminase (ALT), or gamma-glutamyl transferase (GGT) ≥ 3 times upper normal limit\n8. Have attempted suicide in the past 3 years and/or have had serious suicidal intention or plan in the past year\n9. Currently be on prescription medication that contraindicates use of ibudilast (IBUD), including alpha or beta agonists, theophylline, or other sympathomimetic\n10. Currently be on any medications for AUD or any psychotropic medications (e.g., psychostimulants and benzodiazepines) with the exception of stable antidepressants (stable dose for ≥4 weeks)\n11. Have any other circumstances that, in the opinion of the investigators, compromises participant safety.'}, 'identificationModule': {'nctId': 'NCT03594435', 'briefTitle': 'Ibudilast for the Treatment of Alcohol Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'A Randomized Controlled Clinical Trial of the Neuroimmune Modulator Ibudilast for the Treatment of Alcohol Use Disorder', 'orgStudyIdInfo': {'id': '18-000963'}, 'secondaryIdInfos': [{'id': 'R01AA026190', 'link': 'https://reporter.nih.gov/quickSearch/R01AA026190', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ibudilast', 'description': '10mg delayed-release capsules, target dose 50mg twice daily (5 x 10mg capsules twice daily) for 12 weeks', 'interventionNames': ['Drug: Ibudilast']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Oral Capsule', 'description': 'matched to experimental drug', 'interventionNames': ['Drug: Placebo oral capsule']}], 'interventions': [{'name': 'Ibudilast', 'type': 'DRUG', 'otherNames': ['Pinatos', 'MN-166'], 'description': 'targets neurotrophin signaling and neuroimmune function', 'armGroupLabels': ['Ibudilast']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'otherNames': ['Sugar Pill'], 'description': 'matched to active drug, ibudilast', 'armGroupLabels': ['Placebo Oral Capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Addictions Laboratory', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Lara A. Ray, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}, {'name': 'MediciNova', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lara Ray, PhD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}