Nctid:
NCT00000300
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009293", "term"=>"Opioid-Related Disorders"}], "ancestors"=>[{"id"=>"D000079524", "term"=>"Narcotic-Related Disorders"}, {"id"=>"D019966", "term"=>"Substance-Related Disorders"}, {"id"=>"D064419", "term"=>"Chemically-Induced Disorders"}, {"id"=>"D001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M12244", "name"=>"Opioid-Related Disorders", "asFound"=>"Opioid-Related Disorders", "relevance"=>"HIGH"}, {"id"=>"M2057", "name"=>"Narcotic-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M21837", "name"=>"Substance-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M30302", "name"=>"Chemically-Induced Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Substance Related Disorders", "abbrev"=>"BC25"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M27371", "name"=>"Opiate Alkaloids", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>0}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1995-03"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1995-03", "lastUpdateSubmitDate"=>"2017-10-31", "studyFirstSubmitDate"=>"1999-09-20", "studyFirstSubmitQcDate"=>"1999-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2017-11-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-09-21", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Drug use"}, {"measure"=>"Retention"}, {"measure"=>"Increased prosocial behaviors"}, {"measure"=>"Decreased frequency of HIV related behavior"}]}, "conditionsModule"=>{"keywords"=>["opiate", "dependence"], "conditions"=>["Opioid-Related Disorders"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to test therapeutic benefits of take-home LAAM. (1) Do subjects with take-home LAAM availability show increased clinical responsibility over subjects without; (2) Do subjects with take-home LAAM attempt diversion when random recall and other diversion safeguards are used; (3) Does treatment response correlate with background or drug use variables at intake, discharge, or during treatment?", "detailedDescription"=>"1-Year study, participant will be randomly assigned to one of two groups: One will have the opportunity to earn take-home doses by turning in a designated number of clean urines. Two will not have the opportunity to earn take-home doses. Clinic visits three times per week. Urine sample given at each visit."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"99 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nmeets DSM-IV criteria for opiate dependence. M/F, 18 years or older. Certified for LAAm treatment by a physician. Able to understand english. Willing to provide names, addresses, and numbers of 3 relatives who can aid in patient location for follow-up visits.\n\nExclusion Criteria:\n\nHypertensive to LAAM. Pregnant or nursing women. Female of childbearing potential who refuses to use an acceptable form of birth control. Clinically significant abnormality in hematology, blood work, or UA, ETOH and/or sedative/hypnotic dependence according to DSM-IV criteria. Medical or psychiatric illness which would jeopardize safe study participation."}, "identificationModule"=>{"nctId"=>"NCT00000300", "briefTitle"=>"Feasibility Study of Take-Home LAAM Medication - 3", "organization"=>{"class"=>"OTHER", "fullName"=>"University of California, Los Angeles"}, "officialTitle"=>"Feasibility Study of Take-Home LAAM Medication", "orgStudyIdInfo"=>{"id"=>"NIDA-09260-3"}, "secondaryIdInfos"=>[{"id"=>"P50DA009260", "link"=>"https://reporter.nih.gov/quickSearch/P50DA009260", "type"=>"NIH"}, {"id"=>"P50-09260-3"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"LAAM", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90025", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Friends Research Institute", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}], "overallOfficials"=>[{"name"=>"Walter Ling, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Friends Research Institute, Inc."}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of California, Los Angeles", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute on Drug Abuse (NIDA)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Walter Ling", "investigatorAffiliation"=>"University of California, Los Angeles"}}}}