Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-01-01 @ 12:05 AM
Study NCT ID:
NCT04229095
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2020-01-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Medication Development in Alcoholism: Suvorexant Versus Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-01-27', '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': 'C551624', 'term': 'suvorexant'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mason@scripps.edu', 'phone': '(858 784-7324', 'title': 'Dr. Barbara J. Mason, Ph.D. Professor', 'organization': 'The Scripps Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The actual enrollment was 26 subjects, relative to the planned enrollment of 50 subjects, due to chronic staffing problems for overnight studies at the Altman Clinical and Translational Research Institute (ACTRI) at the University of California-San Diego (UCSD) that resulted in multiple pre-randomization visit cancellations. Alternative inpatient beds were not available at general hospitals due to the prioritization of their facilities for COVID-19 patients.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected at all study visits, for any average duration of 3 weeks.', 'description': 'Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse event case report form.', 'eventGroups': [{'id': 'EG000', 'title': 'Belsomra,(Suvorexant)', 'description': '20 mg single-dose administration given on an inpatient clinical research unit\n\nSuvorexant 20 mg: Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 8, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo, (Sugar Pill)', 'description': 'Placebo single-dose administration given on an inpatient clinical research unit\n\nPlacebo oral tablet: Single-dose administration of placebo given on an inpatient clinical research unit', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vivid dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mental fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analogue Scale (VAS) of Craving Severity: 2 Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belsomra,(Suvorexant)', 'description': '20 mg single-dose administration given on an inpatient clinical research unit\n\nSuvorexant 20 mg: Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo single-dose administration given on an inpatient clinical research unit\n\nPlacebo oral tablet: Single-dose administration of placebo given on an inpatient clinical research unit'}], 'classes': [{'categories': [{'measurements': [{'value': '2.38', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '0.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour during cue reactivity session', 'description': 'VAS to alcohol cues minus VAS to water cues on a 0-20 VAS scale. Higher scores indicate greater craving strength with a minimum score of 0 and a maximum score of 20.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Visual Analog Scale (VAS) Strength of Craving: Combined Arms Conditional Model', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Drug/Placebo Condition', 'description': 'The drug and placebo groups were combined for the purposes of the mixed effect model analysis specified in the statistical analysis plan for the primary outcome analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '.94', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.007', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-4.58', 'ciUpperLimit': '-1.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.82', 'estimateComment': 'The effect of the drug on lowering VAS was limited to individuals with impaired sleep at baseline (PSQI \\> or = to 5).', 'groupDescription': 'Mixed effect model with directional hypothesis that drug reduces strength of craving (VAS). Principle predictors were drug condition, and baseline sleep disturbance (Pittsburgh Sleep Quality Index {PSQI} total score less than 5 or 5 and greater). Arms were combined for this analysis.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '1 hour during cue reactivity session', 'description': 'VAS to alcohol cues minus VAS to water cues on a 0-20 VAS scale. Higher scores indicate greater craving strength with a minimum score of 0 and a maximum score of 20.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects'}, {'type': 'SECONDARY', 'title': 'Number of Standard Drinks Per Day: 2 Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belsomra,(Suvorexant)', 'description': '20 mg single-dose administration given on an inpatient clinical research unit\n\nSuvorexant 20 mg: Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit'}, {'id': 'OG001', 'title': 'Placebo, (Sugar Pill)', 'description': 'Placebo single-dose administration given on an inpatient clinical research unit\n\nPlacebo oral tablet: Single-dose administration of placebo given on an inpatient clinical research unit'}], 'classes': [{'categories': [{'measurements': [{'value': '3.59', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '3.46', 'spread': '0.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to one week following single dose administration', 'description': 'Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcohol drinks consumed per day with a minimum value of 0 and an undetermined maximum value', 'unitOfMeasure': 'Standard drinks per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Standard Drinks Per Day: Combined Arms Conditional Model', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Drug/Placebo Condition', 'description': 'The drug and placebo groups were combined for the purposes of the mixed effect model analysis specified in the statistical analysis plan for the primary outcome analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.52', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.0025', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-1.52', 'ciUpperLimit': '-0.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'groupDescription': 'Mixed effect model with directional hypothesis that drug reduces number of drinks per day. Principle predictors were drug condition and sex. Arms were combined for this analysis.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to one week following single dose administration', 'description': 'Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per day with a minimum value of 0 and an undetermined maximum value.', 'unitOfMeasure': 'number of standard drinks per day', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 26 subjects randomized, all 17 subjects that had any follow up drinking data were included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Belsomra,(Suvorexant)', 'description': '20 mg single-dose administration given on an inpatient clinical research unit\n\nSuvorexant 20 mg: Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit'}, {'id': 'FG001', 'title': 'Placebo, (Sugar Pill)', 'description': 'Placebo single-dose administration given on an inpatient clinical research unit\n\nPlacebo oral tablet: Single-dose administration of placebo given on an inpatient clinical research unit'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited for study participation at the Laboratory of Clinical Psychopharmacology at The Scripps Research Institute in La Jolla, California from 09/30/2021-11/08/2022.', 'preAssignmentDetails': 'Thirty-two subjects did not meet admission criteria and 12 subjects declined participation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Belsomra,(Suvorexant)', 'description': '20 mg single-dose administration given on an inpatient clinical research unit\n\nSuvorexant 20 mg: Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit'}, {'id': 'BG001', 'title': 'Placebo, (Sugar Pill)', 'description': 'Placebo single-dose administration given on an inpatient clinical research unit\n\nPlacebo oral tablet: Single-dose administration of placebo given on an inpatient clinical research unit'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.29', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '38.83', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '37.46', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', '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': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'DSM-V symptom Count', 'classes': [{'categories': [{'measurements': [{'value': '6.43', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '8.08', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '7.19', 'spread': '2.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Symptom count from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria for Alcohol Use Disorder (AUD)', 'unitOfMeasure': 'symptom count', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-24', 'size': 1589047, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-01-03T20:57', 'hasProtocol': True}, {'date': '2022-01-09', 'size': 30738, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-01-03T20:57', 'hasProtocol': False}, {'date': '2022-02-24', 'size': 631286, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-01-03T20:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment, Double-Blind, Randomized Stratified at randomization based on sex and Pittsburgh Sleep Quality Index Total Score (PSQI) greater than or equal to 5 versus less than 5.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-04', 'studyFirstSubmitDate': '2020-01-09', 'resultsFirstSubmitDate': '2023-01-03', 'studyFirstSubmitQcDate': '2020-01-13', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-04', 'studyFirstPostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS) of Craving Severity: 2 Arms', 'timeFrame': '1 hour during cue reactivity session', 'description': 'VAS to alcohol cues minus VAS to water cues on a 0-20 VAS scale. Higher scores indicate greater craving strength with a minimum score of 0 and a maximum score of 20.'}, {'measure': 'Visual Analog Scale (VAS) Strength of Craving: Combined Arms Conditional Model', 'timeFrame': '1 hour during cue reactivity session', 'description': 'VAS to alcohol cues minus VAS to water cues on a 0-20 VAS scale. Higher scores indicate greater craving strength with a minimum score of 0 and a maximum score of 20.'}], 'secondaryOutcomes': [{'measure': 'Number of Standard Drinks Per Day: 2 Arms', 'timeFrame': 'Up to one week following single dose administration', 'description': 'Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcohol drinks consumed per day with a minimum value of 0 and an undetermined maximum value'}, {'measure': 'Number of Standard Drinks Per Day: Combined Arms Conditional Model', 'timeFrame': 'Up to one week following single dose administration', 'description': 'Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per day with a minimum value of 0 and an undetermined maximum value.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder (AUD)']}, 'descriptionModule': {'briefSummary': 'The primary hypotheses under test are that alcohol dependent subjects treated with suvorexant will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo. Suvorexant (Belsomra®) received approval by the FDA in 2014 for treatment of insomnia. To control for any effect of pre-existing sleep disturbance for which suvorexant may be indicated, subjects will be stratified on the basis of a Pittsburgh Sleep Quality Index total score of \\> 5 versus \\<5. Subjects were also stratified by sex.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female volunteers, 18-65 years of age.\n* Meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for current alcohol use disorder of moderate or greater severity (AUD-MS).\n* In the month prior to screening, reports drinking ≥ 21 standard drinks per week if male, ≥ 14 if female, with at least one heavy drinking day (≥ 5 males, ≥ 4 females) per week.\n* Subjects will not be seeking treatment because the medication studies are not treatment trials, and to avoid exposing treatment-seekers to alcohol cues\n* Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session.\n* Negative blood alcohol content (BAC) and a Clinical Institute Withdrawal Assessment (CIWA) score of \\< 9 at time of randomization and lab session to eliminate acute alcohol or withdrawal effects on dependent measures.\n* In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, EKG, routine urine and blood chemistry.\n* Subjects with a history of depression, who have been on a stable dose of anti-depressant medication for at least 3 months, and do not meet current DSM-5 criteria for depression or anxiety.\n* Females with childbearing potential must have a negative pregnancy test on the screening and randomization visits and agree to use effective birth control for the duration required by a given study.\n* Able to provide informed consent and understand questionnaires and study procedures in English.\n* Willing to comply with the provisions of the protocol and take oral medication.\n\nExclusion Criteria:\n\n* Meets DSM-5 criteria for a major psychiatric disorder, including mood or anxiety disorders or substance use disorders other than alcohol or nicotine, or, mild cannabis use disorder\n* Has a urine drug screen (UDS) positive for substances of abuse other than alcohol or marijuana\n* Significant medical disorders that will increase potential risk or interfere with study participation as determined by the study physician.\n* Liver function tests more than 3 times the upper limit of normal or elevated bilirubin.\n* Subjects taking digoxin or CYP3A inhibitors or inducers, metabolism by CYP3A is the major elimination pathway for suvorexant.\n* Treatment within the month prior to screening with (1) an investigational drug, (2) medications which may negatively interact with study medications, or (3) drugs that may influence study outcomes (e.g., disulfiram \\[Antabuse\\], naltrexone \\[ReVia\\], acamprosate \\[Campral\\], or anticonvulsants).\n* Ongoing treatment with medications that may increase risk, including prescribed, over-the-counter, and herbal preparations, as determined by the study physician.\n* Sexually active female subjects with childbearing potential who are pregnant, nursing, or refuse to use effective methods of birth control for the duration of the study.\n* No fixed domicile and/or no availability by home or mobile telephone.\n* History of hypersensitivity to the study drug or the ingredients.\n* Failure to take double-blind medication as prescribed.'}, 'identificationModule': {'nctId': 'NCT04229095', 'briefTitle': 'Medication Development in Alcoholism: Suvorexant Versus Placebo', 'organization': {'class': 'OTHER', 'fullName': 'The Scripps Research Institute'}, 'officialTitle': 'Medication Development for Protracted Abstinence in Alcoholism: Suvorexant Versus Placebo', 'orgStudyIdInfo': {'id': 'P60AA006420', 'link': 'https://reporter.nih.gov/quickSearch/P60AA006420', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'P60AA006420', 'link': 'https://reporter.nih.gov/quickSearch/P60AA006420', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Belsomra,(suvorexant)', 'description': '20 mg single-dose administration given on an inpatient clinical research unit', 'interventionNames': ['Drug: Suvorexant 20 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo single-dose administration given on an inpatient clinical research unit', 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'Suvorexant 20 mg', 'type': 'DRUG', 'otherNames': ['Belsomra'], 'description': 'Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit', 'armGroupLabels': ['Belsomra,(suvorexant)']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'otherNames': ['Sugar pill'], 'description': 'Single-dose administration of placebo given on an inpatient clinical research unit', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037-4657', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Research', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Barbara J. Mason, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Scripps Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Scripps Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}