{ "FullStudy":{ "Rank":218184, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511640", "OrgStudyIdInfo":{ "OrgStudyId":"R01DA036550", "OrgStudyIdType":"U.S. NIH Grant/Contract", "OrgStudyIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=R01DA036550&Fy=all" }, "Organization":{ "OrgFullName":"University of Kentucky", "OrgClass":"OTHER" }, "BriefTitle":"Behavioral Effects of Pregabalin and Cannabis", "OfficialTitle":"Behavioral Effects of Drugs (Outpatient)(43)" }, "StatusModule":{ "StatusVerifiedDate":"May 2019", "OverallStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 1, 2017", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 30, 2021", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"December 31, 2021", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 9, 2012", "StudyFirstSubmitQCDate":"January 12, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 2, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 6, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor-Investigator", "ResponsiblePartyInvestigatorFullName":"Joshua A. Lile, Ph.D.", "ResponsiblePartyInvestigatorTitle":"Associate Professor of Behavioral Science", "ResponsiblePartyInvestigatorAffiliation":"University of Kentucky" }, "LeadSponsor":{ "LeadSponsorName":"Joshua A. Lile, Ph.D.", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No", "IsFDARegulatedDrug":"Yes", "IsFDARegulatedDevice":"No" }, "DescriptionModule":{ "BriefSummary":"Cannabis is the most commonly used illicit drug in the United States, and its use is associated with rates of development of abuse and dependence, treatment admission and relapse that are comparable to other illicit drugs. Currently there is no effective pharmacological treatment for cannabis-use disorders. The purpose of the present study is to evaluate the ability of pregabalin to reduce cannabis use thereby evaluating its effectiveness as a medication for cannabis-use disorders." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Cannabis-use Disorders" ] }, "KeywordList":{ "Keyword":[ "marijuana", "addiction", "treatment", "pharmacotherapy", "cannabinoid" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Early Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"26", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Pregabalin 1", "ArmGroupType":"Experimental", "ArmGroupDescription":"Dose 1", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Pregabalin" ] } },{ "ArmGroupLabel":"Placebo 1", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Placebo 1", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } },{ "ArmGroupLabel":"Pregabalin 2", "ArmGroupType":"Experimental", "ArmGroupDescription":"Dose 2", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Pregabalin" ] } },{ "ArmGroupLabel":"Placebo 2", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Placebo 2", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Pregabalin", "InterventionDescription":"pregabalin 2x daily for duration of study", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Pregabalin 1", "Pregabalin 2" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"placebo 2x daily for duration of study", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo 1", "Placebo 2" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"number of self-administered puffs of smoked cannabis containing active THC concentrations compared to placebo under controlled laboratory conditions", "PrimaryOutcomeTimeFrame":"22 days" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nregular cannabis use\ngood health other than cannabis use\nwillingness to attempt abstinence\neffective form of birth control in female subjects\navailable for up to 6 hrs every day for two 2-week test periods with an intervening break of 7-10 days each\nlocated in close proximity to University of Kentucky\n\nExclusion Criteria:\n\nmedical screening outcomes outside normal ranges or deemed clinically insignificant\nmedical history that would contraindicate pregabalin administration", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"50 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Joshua A. Lile, Ph.D.", "OverallOfficialAffiliation":"University of Kentucky", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Laboratory of Human Behavioral Pharmacology", "LocationStatus":"Recruiting", "LocationCity":"Lexington", "LocationState":"Kentucky", "LocationZip":"40536-0086", "LocationCountry":"United States", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Frances Wagner, RN", "LocationContactRole":"Contact", "LocationContactPhone":"859-257-5388", "LocationContactEMail":"fpwagn2@uky.edu" },{ "LocationContactName":"Joshua A. Lile, Ph.D.", "LocationContactRole":"Principal Investigator" } ] } } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"No" } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000069583", "InterventionMeshTerm":"Pregabalin" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000700", "InterventionAncestorTerm":"Analgesics" },{ "InterventionAncestorId":"D000018689", "InterventionAncestorTerm":"Sensory System Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000927", "InterventionAncestorTerm":"Anticonvulsants" },{ "InterventionAncestorId":"D000002121", "InterventionAncestorTerm":"Calcium Channel Blockers" },{ "InterventionAncestorId":"D000049990", "InterventionAncestorTerm":"Membrane Transport Modulators" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000077264", "InterventionAncestorTerm":"Calcium-Regulating Hormones and Agents" },{ "InterventionAncestorId":"D000014151", "InterventionAncestorTerm":"Anti-Anxiety Agents" },{ "InterventionAncestorId":"D000014149", "InterventionAncestorTerm":"Tranquilizing Agents" },{ "InterventionAncestorId":"D000002492", "InterventionAncestorTerm":"Central Nervous System Depressants" },{ "InterventionAncestorId":"D000011619", "InterventionAncestorTerm":"Psychotropic Drugs" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M476", "InterventionBrowseLeafName":"Pregabalin", "InterventionBrowseLeafAsFound":"Pregabalin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2613", "InterventionBrowseLeafName":"Analgesics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2827", "InterventionBrowseLeafName":"Anticonvulsants", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3963", "InterventionBrowseLeafName":"Calcium", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3980", "InterventionBrowseLeafName":"Calcium, Dietary", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3966", "InterventionBrowseLeafName":"Calcium Channel Blockers", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8372", "InterventionBrowseLeafName":"Hormones", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15488", "InterventionBrowseLeafName":"Anti-Anxiety Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M13057", "InterventionBrowseLeafName":"Psychotropic Drugs", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ChanBlk", "InterventionBrowseBranchName":"Channel Blockers" },{ "InterventionBrowseBranchAbbrev":"Analg", "InterventionBrowseBranchName":"Analgesics" },{ "InterventionBrowseBranchAbbrev":"AntiConv", "InterventionBrowseBranchName":"Anticonvulsants" },{ "InterventionBrowseBranchAbbrev":"CNSDep", "InterventionBrowseBranchName":"Central Nervous System Depressants" },{ "InterventionBrowseBranchAbbrev":"PsychDr", "InterventionBrowseBranchName":"Psychotropic Drugs" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"BDCA", "InterventionBrowseBranchName":"Bone Density Conservation Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000002189", "ConditionMeshTerm":"Marijuana Abuse" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000019966", "ConditionAncestorTerm":"Substance-Related Disorders" },{ "ConditionAncestorId":"D000064419", "ConditionAncestorTerm":"Chemically-Induced Disorders" },{ "ConditionAncestorId":"D000001523", "ConditionAncestorTerm":"Mental Disorders" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M17683", "ConditionBrowseLeafName":"Behavior, Addictive", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4031", "ConditionBrowseLeafName":"Marijuana Abuse", "ConditionBrowseLeafAsFound":"Cannabis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M20421", "ConditionBrowseLeafName":"Substance-Related Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M28889", "ConditionBrowseLeafName":"Chemically-Induced Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3396", "ConditionBrowseLeafName":"Mental Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13056", "ConditionBrowseLeafName":"Psychotic Disorders", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BXM", "ConditionBrowseBranchName":"Behaviors and Mental Disorders" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC25", "ConditionBrowseBranchName":"Substance Related Disorders" } ] } } } } } }