Nctid:
NCT00000326
Payload:
{"FullStudy"=>{"Rank"=>474069, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"November 27, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000009293", "ConditionMeshTerm"=>"Opioid-Related Disorders"}, {"ConditionMeshId"=>"D000006556", "ConditionMeshTerm"=>"Heroin Dependence"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000079524", "ConditionAncestorTerm"=>"Narcotic-Related Disorders"}, {"ConditionAncestorId"=>"D000019966", "ConditionAncestorTerm"=>"Substance-Related Disorders"}, {"ConditionAncestorId"=>"D000064419", "ConditionAncestorTerm"=>"Chemically-Induced Disorders"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M11934", "ConditionBrowseLeafName"=>"Opioid-Related Disorders", "ConditionBrowseLeafAsFound"=>"Opioid-Related Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9324", "ConditionBrowseLeafName"=>"Heroin Dependence", "ConditionBrowseLeafAsFound"=>"Heroin Dependence", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M2057", "ConditionBrowseLeafName"=>"Narcotic-Related Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M21527", "ConditionBrowseLeafName"=>"Substance-Related Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M29992", "ConditionBrowseLeafName"=>"Chemically-Induced Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4505", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14163", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Substance Related Disorders", "ConditionBrowseBranchAbbrev"=>"BC25"}, {"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000003932", "InterventionMeshTerm"=>"Heroin"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000701", "InterventionAncestorTerm"=>"Analgesics, Opioid"}, {"InterventionAncestorId"=>"D000009294", "InterventionAncestorTerm"=>"Narcotics"}, {"InterventionAncestorId"=>"D000002492", "InterventionAncestorTerm"=>"Central Nervous System Depressants"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000000700", "InterventionAncestorTerm"=>"Analgesics"}, {"InterventionAncestorId"=>"D000018689", "InterventionAncestorTerm"=>"Sensory System Agents"}, {"InterventionAncestorId"=>"D000018373", "InterventionAncestorTerm"=>"Peripheral Nervous System Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M5007", "InterventionBrowseLeafName"=>"Buprenorphine", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M11911", "InterventionBrowseLeafName"=>"Naloxone", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3723", "InterventionBrowseLeafName"=>"Analgesics, Opioid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M6817", "InterventionBrowseLeafName"=>"Heroin", "InterventionBrowseLeafAsFound"=>"Eagle", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3722", "InterventionBrowseLeafName"=>"Analgesics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M11935", "InterventionBrowseLeafName"=>"Narcotics", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Analgesics", "InterventionBrowseBranchAbbrev"=>"Analg"}, {"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"InterventionBrowseBranchName"=>"Narcotic Antagonists", "InterventionBrowseBranchAbbrev"=>"NarcAntag"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignMaskingInfo"=>{"DesignMasking"=>"Double"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Crossover Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"0"}}, "StatusModule"=>{"OverallStatus"=>"Withdrawn", "StartDateStruct"=>{"StartDate"=>"April 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"May 2017", "CompletionDateStruct"=>{"CompletionDate"=>"August 1997", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"May 2, 2017", "StudyFirstSubmitDate"=>"September 20, 1999", "StudyFirstSubmitQCDate"=>"September 20, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"May 4, 2017", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"September 21, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"August 1997", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Drug use"}, {"PrimaryOutcomeMeasure"=>"Retention"}, {"PrimaryOutcomeMeasure"=>"Subjective dose estimate"}, {"PrimaryOutcomeMeasure"=>"Observed withdrawal rating"}, {"PrimaryOutcomeMeasure"=>"Opioid agonist rating"}, {"PrimaryOutcomeMeasure"=>"Opioid antagonist rating"}, {"PrimaryOutcomeMeasure"=>"Pupil diameter"}, {"PrimaryOutcomeMeasure"=>"Compliance"}, {"PrimaryOutcomeMeasure"=>"Analog rating scale for drug effects"}, {"PrimaryOutcomeMeasure"=>"Drug effect characteristics"}, {"PrimaryOutcomeMeasure"=>"Dose order estimate-nurse"}, {"PrimaryOutcomeMeasure"=>"Dose order estimate-client"}]}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Heroin Dependence"]}, "ConditionList"=>{"Condition"=>["Heroin Dependence", "Opioid-Related Disorders"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferenceType"=>"background", "ReferenceCitation"=>"(presented at ACNP 1997. Kamien, J.B., Mikulich, S.K., and Amass, L., Efficacy of the buprenorphine/naloxone tablet for daily vs. alternate-day opioid dependence treatment. Presented to the 1998 Meeting of the College on Problems of Drug Dependence.. Presented at ACNP 1997 and CPDD 1998."}]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.", "DetailedDescription"=>"Alternate-day dosing with the 8mg buprenorphine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided during alternate-day dosing is equal to that given during daily dosing."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"64 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nIndividuals must be currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.\n\nExclusion Criteria:\n\nIndividuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation."}, "IdentificationModule"=>{"NCTId"=>"NCT00000326", "BriefTitle"=>"Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"University of Colorado, Denver"}, "OfficialTitle"=>"Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1(1)", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NIDA-11160-1"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"1R01DA011160", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/1R01DA011160", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"R01-11160-1"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Heroin Dependence", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"80206", "LocationCity"=>"Denver", "LocationState"=>"Colorado", "LocationCountry"=>"United States", "LocationFacility"=>"University of Colorado Health Sciences Center"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Leslie Amass, Ph.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"University of Colorado, Denver"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"University of Colorado, Denver", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute on Drug Abuse (NIDA)", "CollaboratorClass"=>"NIH"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
