{ "FullStudy":{ "Rank":217617, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519063", "OrgStudyIdInfo":{ "OrgStudyId":"1005006779" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"P50AA012870", "SecondaryIdType":"U.S. NIH Grant/Contract", "SecondaryIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=P50AA012870&Fy=all" } ] }, "Organization":{ "OrgFullName":"Yale University", "OrgClass":"OTHER" }, "BriefTitle":"Naltrexone and Memantine Effects on Alcohol Drinking Behaviors", "OfficialTitle":"Glutamate-opioid Interactions in Alcohol Drinking Behaviors" }, "StatusModule":{ "StatusVerifiedDate":"March 2020", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"March 29, 2017", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 1, 2017", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 23, 2012", "StudyFirstSubmitQCDate":"January 25, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"June 29, 2018", "ResultsFirstSubmitQCDate":"June 17, 2019", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"July 10, 2019", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"March 5, 2020", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 9, 2020", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Yale University", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"National Institute on Alcohol Abuse and Alcoholism (NIAAA)", "CollaboratorClass":"NIH" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the combined effects of the study medications naltrexone and memantine on alcohol drinking behaviors.", "DetailedDescription":"Participants will be randomized to receive a combination of naltrexone/memantine over a one week period and then participate in a laboratory session. During this session, participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. These medications are hypothesized to reduce craving and number of drinks consumed prior to and after exposure to the initial drink of alcohol and during the three hour drinking period." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Alcohol Drinking" ] }, "KeywordList":{ "Keyword":[ "Alcohol", "Drinking", "Drinkers", "Alcohol Drinking", "Memantine", "Naltrexone", "Alcohol Dependence", "Alcohol Abuse", "Alcohol-Related Disorders", "Ethanol", "Alcoholism" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Other", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"75", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Naltrexone and memantine", "ArmGroupType":"Experimental", "ArmGroupDescription":"Treatment with Naltrexone and memantine first", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Naltrexone and memantine first", "Drug: Naltrexone and Placebo first" ] } },{ "ArmGroupLabel":"Naltrexone and Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Treatment with naltrexone and placebo first", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Naltrexone and memantine first", "Drug: Naltrexone and Placebo first" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Naltrexone and memantine first", "InterventionDescription":"Naltrexone 50mg memantine 20mg", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Naltrexone and Placebo", "Naltrexone and memantine" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "memantine's brand name is Namenda", "naltrexone's brand name is Revia" ] } },{ "InterventionType":"Drug", "InterventionName":"Naltrexone and Placebo first", "InterventionDescription":"Naltrexone 50 mg Placebo", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Naltrexone and Placebo", "Naltrexone and memantine" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "naltrexone's brand name is Revia" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Number of Drinks Consumed at Lab Session (Day 7)", "PrimaryOutcomeDescription":"Number of drinks consumed during the lab session (Day 7) after taking study medication, ranging from 0-12.", "PrimaryOutcomeTimeFrame":"Day 7" },{ "PrimaryOutcomeMeasure":"Craving AUC: Adlib Drinking Phase", "PrimaryOutcomeDescription":"Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher craving scores (ranging from 0-56) are indicated by larger log-transformed AUC.", "PrimaryOutcomeTimeFrame":"50-230 minutes after the priming drink during lab session" },{ "PrimaryOutcomeMeasure":"Stimulation Response to Alcohol at Lab Session", "PrimaryOutcomeDescription":"Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher stimulation scores (ranging from 0-70) are indicated by larger log-transformed AUC.", "PrimaryOutcomeTimeFrame":"50-230 minutes after the priming drink during lab session" },{ "PrimaryOutcomeMeasure":"Sedation Response to Alcohol at Lab Session", "PrimaryOutcomeDescription":"Brief Biphasic Alcohol Effects Scale-Sedation subscale (BAES; Martin et al., 1993), measuring sedation effects of alcohol. The seven items included on the sedation subscale range from 1 (not at all) to extremely (10) with higher measurements indicating higher sedation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Area Under the Curve was used to calculate the final score reported for the BAES.\n\nAs a single summary measure, AUC, was calculated for BAES outcomes based on scores recorded at numerous time points throughout the adlib drinking session The calculation was based on the trapezoidal methods using times 50, 90, 110, 150, 170, 210, and 230 . Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater levels of sedation.", "PrimaryOutcomeTimeFrame":"50-230 minutes after the priming drink during lab session" },{ "PrimaryOutcomeMeasure":"Craving AUC: Priming Dose Phase", "PrimaryOutcomeDescription":"Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Craving for alcohol based on Alcohol Urge Questionnaire is calculated using Area Under the Curve (AUC). A single summary measure, AUC was calculated for AUQ outcomes based on scores recorded at numerous time points throughout the priming drink session. The calculation was based on the trapezoidal methods using times -20, 10, 20, 30, 40, 50 minutes before/after priming drink. Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater alcohol urge.", "PrimaryOutcomeTimeFrame":"0-50 minutes after the priming drink" },{ "PrimaryOutcomeMeasure":"Sedation Response to Alcohol: Priming Dose Phase", "PrimaryOutcomeDescription":"Brief Biphasic Alcohol Effects Scale-Sedation subscale, measuring sedation effects of alcohol with higher measurements indicating higher sedation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed.", "PrimaryOutcomeTimeFrame":"0-50 minutes after priming drink" },{ "PrimaryOutcomeMeasure":"Stimulation Response to Alcohol: Priming Dose Phase", "PrimaryOutcomeDescription":"Brief Biphasic Alcohol Effects Scale-Stimulation subscale, measuring stimulation effects of alcohol with higher measurements indicating higher stimulation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed.", "PrimaryOutcomeTimeFrame":"0-50 minutes after priming drink" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAges 21-55\nAble to read English at 6th grade level or higher and to complete study evaluations\nRegular alcohol drinker\n\nExclusion Criteria:\n\nIndividuals who are seeking alcohol treatment\nMedical conditions that would contraindicate the use of study medication\nRegular use of other substances", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"21 Years", "MaximumAge":"55 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Suchitra Krishnan-Sarin, Ph.D.", "OverallOfficialAffiliation":"Yale University", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Sac, Cmhc", "LocationCity":"New Haven", "LocationState":"Connecticut", "LocationZip":"06519", "LocationCountry":"United States" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"The number of participants enrolled was 75. However, 19 people did not start medication due to ineligibility or drop out, leaving 56 total participants.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Naltrexone and Memantine First", "FlowGroupDescription":"Patients received Naltrexone and Memantine first in this arm." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Naltrexone and Placebo First", "FlowGroupDescription":"Patients received Naltrexone and Placebo first in this arm." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"26" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"30" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"19" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"25" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"7" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"5" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Naltrexone and Memantine First", "BaselineGroupDescription":"Patients in this arm received Naltrexone and Memantine first." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Naltrexone and Placebo First", "BaselineGroupDescription":"Patients in this arm received Naltrexone and Placebo first." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"26" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"30" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"56" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"34", "BaselineMeasurementSpread":"8.5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"33", "BaselineMeasurementSpread":"9.3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"33", "BaselineMeasurementSpread":"8.9" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"23" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"18" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"33" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race/Ethnicity, Customized", "BaselineMeasureDescription":"Number of Caucasian and Non-Caucasian participants", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Caucasian", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"36" } ] } } ] } },{ "BaselineClassTitle":"Non-Caucasian", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"20" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Total number of drinks over past 90 days", "BaselineMeasureDescription":"Timeline Followback (TLFB; Sobell & Sobell, 1996)", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"drinks", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"166", "BaselineMeasurementSpread":"63" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"165", "BaselineMeasurementSpread":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"165", "BaselineMeasurementSpread":"72" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Drinks per drinking day in past 90 days", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"drinks", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7.2", "BaselineMeasurementSpread":"2.5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"7.2", "BaselineMeasurementSpread":"2.9" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"7.2", "BaselineMeasurementSpread":"2.7" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Percent of drinking days over past 90 days", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"percent of days", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"78", "BaselineMeasurementSpread":"16" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"75", "BaselineMeasurementSpread":"17" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"76", "BaselineMeasurementSpread":"16" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Drinks Consumed at Lab Session (Day 7)", "OutcomeMeasureDescription":"Number of drinks consumed during the lab session (Day 7) after taking study medication, ranging from 0-12.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"drinks", "OutcomeMeasureTimeFrame":"Day 7", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Naltrexone and Memantine", "OutcomeGroupDescription":"Treatment with Naltrexone and memantine\n\nNaltrexone and memantine: Naltrexone 50mg memantine 20mg" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Naltrexone and Placebo", "OutcomeGroupDescription":"Treatment with naltrexone and placebo\n\nNaltrexone and Placebo: Naltrexone 50 mg Placebo" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"47" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"46" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.11", "OutcomeMeasurementSpread":"4.19" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5.02", "OutcomeMeasurementSpread":"4.32" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Craving AUC: Adlib Drinking Phase", "OutcomeMeasureDescription":"Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher craving scores (ranging from 0-56) are indicated by larger log-transformed AUC.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log (units on a scale * minutes)", "OutcomeMeasureTimeFrame":"50-230 minutes after the priming drink during lab session", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Naltrexone and Memantine", "OutcomeGroupDescription":"Treatment with Naltrexone and memantine\n\nNaltrexone and memantine: Naltrexone 50mg memantine 20mg" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Naltrexone and Placebo", "OutcomeGroupDescription":"Treatment with naltrexone and placebo\n\nNaltrexone and Placebo: Naltrexone 50 mg Placebo" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"47" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"46" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.62", "OutcomeMeasurementSpread":".54" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.75", "OutcomeMeasurementSpread":".55" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Stimulation Response to Alcohol at Lab Session", "OutcomeMeasureDescription":"Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher stimulation scores (ranging from 0-70) are indicated by larger log-transformed AUC.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log (units on a scale *minutes)", "OutcomeMeasureTimeFrame":"50-230 minutes after the priming drink during lab session", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Naltrexone and Memantine", "OutcomeGroupDescription":"Treatment with Naltrexone and memantine\n\nNaltrexone and memantine: Naltrexone 50mg memantine 20mg" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Naltrexone and Placebo", "OutcomeGroupDescription":"Treatment with naltrexone and placebo\n\nNaltrexone and Placebo: Naltrexone 50 mg Placebo" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"47" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"46" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.78", "OutcomeMeasurementSpread":"3.51" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.93", "OutcomeMeasurementSpread":"3.45" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Sedation Response to Alcohol at Lab Session", "OutcomeMeasureDescription":"Brief Biphasic Alcohol Effects Scale-Sedation subscale (BAES; Martin et al., 1993), measuring sedation effects of alcohol. The seven items included on the sedation subscale range from 1 (not at all) to extremely (10) with higher measurements indicating higher sedation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Area Under the Curve was used to calculate the final score reported for the BAES.\n\nAs a single summary measure, AUC, was calculated for BAES outcomes based on scores recorded at numerous time points throughout the adlib drinking session The calculation was based on the trapezoidal methods using times 50, 90, 110, 150, 170, 210, and 230 . Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater levels of sedation.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log (units on a scale *minutes)", "OutcomeMeasureTimeFrame":"50-230 minutes after the priming drink during lab session", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Naltrexone and Memantine", "OutcomeGroupDescription":"Treatment with Naltrexone and memantine\n\nNaltrexone and memantine: Naltrexone 50mg memantine 20mg" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Naltrexone and Placebo", "OutcomeGroupDescription":"Treatment with naltrexone and placebo\n\nNaltrexone and Placebo: Naltrexone 50 mg Placebo" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"47" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"46" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.42", "OutcomeMeasurementSpread":"2.97" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5.34", "OutcomeMeasurementSpread":"3.08" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Craving AUC: Priming Dose Phase", "OutcomeMeasureDescription":"Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Craving for alcohol based on Alcohol Urge Questionnaire is calculated using Area Under the Curve (AUC). A single summary measure, AUC was calculated for AUQ outcomes based on scores recorded at numerous time points throughout the priming drink session. The calculation was based on the trapezoidal methods using times -20, 10, 20, 30, 40, 50 minutes before/after priming drink. Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater alcohol urge.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log (units on a scale *minutes)", "OutcomeMeasureTimeFrame":"0-50 minutes after the priming drink", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Naltrexone and Memantine", "OutcomeGroupDescription":"Treatment with Naltrexone and memantine\n\nNaltrexone and memantine: Naltrexone 50mg memantine 20mg" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Naltrexone and Placebo", "OutcomeGroupDescription":"Treatment with naltrexone and placebo\n\nNaltrexone and Placebo: Naltrexone 50 mg Placebo" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"47" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"46" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.81", "OutcomeMeasurementSpread":".55" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.84", "OutcomeMeasurementSpread":".57" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Sedation Response to Alcohol: Priming Dose Phase", "OutcomeMeasureDescription":"Brief Biphasic Alcohol Effects Scale-Sedation subscale, measuring sedation effects of alcohol with higher measurements indicating higher sedation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log (units on a scale)", "OutcomeMeasureTimeFrame":"0-50 minutes after priming drink", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Naltrexone and Memantine", "OutcomeGroupDescription":"Treatment with Naltrexone and memantine\n\nNaltrexone and memantine: Naltrexone 50mg memantine 20mg" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Naltrexone and Placebo", "OutcomeGroupDescription":"Treatment with naltrexone and placebo\n\nNaltrexone and Placebo: Naltrexone 50 mg Placebo" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"47" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"46" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.87", "OutcomeMeasurementSpread":"2.49" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.76", "OutcomeMeasurementSpread":"2.34" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Stimulation Response to Alcohol: Priming Dose Phase", "OutcomeMeasureDescription":"Brief Biphasic Alcohol Effects Scale-Stimulation subscale, measuring stimulation effects of alcohol with higher measurements indicating higher stimulation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log (units on a scale)", "OutcomeMeasureTimeFrame":"0-50 minutes after priming drink", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Naltrexone and Memantine", "OutcomeGroupDescription":"Treatment with Naltrexone and memantine\n\nNaltrexone and memantine: Naltrexone 50mg memantine 20mg" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Naltrexone and Placebo", "OutcomeGroupDescription":"Treatment with naltrexone and placebo\n\nNaltrexone and Placebo: Naltrexone 50 mg Placebo" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"47" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"46" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.20", "OutcomeMeasurementSpread":"2.84" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.43", "OutcomeMeasurementSpread":"2.71" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Naltrexone and Memantine", "EventGroupDescription":"Treatment with Naltrexone and memantine\n\nNaltrexone and memantine: Naltrexone 50mg memantine 20mg", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"47", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"47", "EventGroupOtherNumAffected":"3", "EventGroupOtherNumAtRisk":"47" },{ "EventGroupId":"EG001", "EventGroupTitle":"Naltrexone and Placebo", "EventGroupDescription":"Treatment with naltrexone and placebo\n\nNaltrexone and Placebo: Naltrexone 50 mg Placebo", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"46", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"46", "EventGroupOtherNumAffected":"3", "EventGroupOtherNumAtRisk":"46" } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Nausea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"47" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"46" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"Yes", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Dana Cavallo, Assistant Professor", "PointOfContactOrganization":"Yale University", "PointOfContactEMail":"dana.cavallo@yale.edu", "PointOfContactPhone":"203974-7607" } } }, "DocumentSection":{ "LargeDocumentModule":{ "LargeDocList":{ "LargeDoc":[ { "LargeDocTypeAbbrev":"Prot_SAP", "LargeDocHasProtocol":"Yes", "LargeDocHasSAP":"Yes", "LargeDocHasICF":"No", "LargeDocLabel":"Study Protocol and Statistical Analysis Plan", "LargeDocDate":"December 7, 2016", "LargeDocUploadDate":"06/25/2018 13:08", "LargeDocFilename":"Prot_SAP_000.pdf" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000009271", "InterventionMeshTerm":"Naltrexone" },{ "InterventionMeshId":"D000008559", "InterventionMeshTerm":"Memantine" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { 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