{"protocolSection":{"identificationModule":{"nctId":"NCT00218036","orgStudyIdInfo":{"id":"NIDA-09262-8"},"secondaryIdInfos":[{"id":"P50DA009262-08","type":"NIH","link":"https://reporter.nih.gov/quickSearch/P50DA009262-08"},{"id":"DPMC","type":"OTHER","domain":"NIDA"}],"organization":{"fullName":"The University of Texas Health Science Center, Houston","class":"OTHER"},"briefTitle":"Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8","officialTitle":"Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals"},"statusModule":{"statusVerifiedDate":"2018-10","overallStatus":"TERMINATED","whyStopped":"PI left institution, end of funding, clinic relocation, recruitment issues","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-07"},"primaryCompletionDateStruct":{"date":"2010-02","type":"ACTUAL"},"completionDateStruct":{"date":"2010-02","type":"ACTUAL"},"studyFirstSubmitDate":"2005-09-16","studyFirstSubmitQcDate":"2005-09-16","studyFirstPostDateStruct":{"date":"2005-09-22","type":"ESTIMATED"},"resultsFirstSubmitDate":"2018-05-01","resultsFirstSubmitQcDate":"2018-10-19","resultsFirstPostDateStruct":{"date":"2018-11-16","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-10-19","lastUpdatePostDateStruct":{"date":"2018-11-16","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Joy Schmitz","investigatorTitle":"Professor - Psy, Behavioral Science","investigatorAffiliation":"The University of Texas Health Science Center, Houston"},"leadSponsor":{"name":"The University of Texas Health Science Center, Houston","class":"OTHER"},"collaborators":[{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"},{"name":"University of Texas","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this study is to examine two medications, modafinil and citalopram, in the treatment of cocaine dependent individuals who are maintained on methadone.","detailedDescription":"This is a 24-week, randomized, double-blind, placebo-controlled study examining two doses of modafinil (200 and 400 mg) and citalopram (20 and 40 mg) in the treatment of methadone maintained cocaine dependent individuals.\n\nParticipants will first be given methadone to determine its tolerated and effective doses. Most participants will be able to reach a stable dose of methadone within 7 to 10 days of methadone initiation. When 80% of the projected dose of methadone has been achieved, participants will begin the medication regimen of modafinil or citalopram. Modafinil will be given over a 7-day period. Dosing of modafinil will begin at 200 mg and, depending on the individual, may increase to 400 mg. Citalopram will be given in increasing doses, starting at 20 mg and increasing to 40mg."},"conditionsModule":{"conditions":["Cocaine Abuse","Opiate Dependence"],"keywords":["Cocaine Abuse","Opiate Abuse"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":54,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1","type":"EXPERIMENTAL","description":"Modafinil 200mg / Methadone Maintenance (1.2mg/kg)","interventionNames":["Drug: Modafinil 200mg"]},{"label":"2","type":"EXPERIMENTAL","description":"Modafinil 400mg/ Methadone Maintenance (1.2mg/kg)","interventionNames":["Drug: Modafinil 400mg"]},{"label":"3","type":"EXPERIMENTAL","description":"Citalopram 20/ Methadone Maintenance 1.2mg/kg","interventionNames":["Drug: Citalopram 20mg"]},{"label":"4","type":"EXPERIMENTAL","description":"Citalopram 40/ Methadone Maintenance 1.2 mg/kg","interventionNames":["Drug: Citalopram 40mg"]},{"label":"5","type":"PLACEBO_COMPARATOR","description":"Placebo given to methadone-maintained subjects (1.2mg/kg) for the duration of the 12-week study","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Modafinil 200mg","description":"10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1/2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.","armGroupLabels":["1"]},{"type":"DRUG","name":"Modafinil 400mg","description":"10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.","armGroupLabels":["2"]},{"type":"DRUG","name":"Citalopram 20mg","description":"10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days.","armGroupLabels":["3"]},{"type":"DRUG","name":"Citalopram 40mg","description":"10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days.","armGroupLabels":["4"]},{"type":"DRUG","name":"Placebo","description":"Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg","armGroupLabels":["5"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Confirmed Abstinence From Cocaine","timeFrame":"12 weeks of treatment"}],"secondaryOutcomes":[{"measure":"Retention","timeFrame":"12 weeks of treatment"},{"measure":"Medication Compliance","timeFrame":"12 weeks of treatment"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Meets cocaine abuse and dependence criteria (as determined by the SCID)\n* Meets opiate dependence criteria (as determined by the SCID)\n* In good general physical and psychiatric health (except for possible acute drug use related problems)\n\nExclusion Criteria:\n\n* Meets diagnostic criteria for other psychiatric disorders, including other forms of drug dependence (other than nicotine)\n* Current cardiovascular disease (as determined by an electrocardiogram)\n* Circumstances will not allow for completion of study (on probation or parole)\n* Ethical constraints of supervision do not allow confidentiality (on probation or parole)","healthyVolunteers":true,"sex":"ALL","minimumAge":"22 Years","maximumAge":"50 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Joy M Schmitz, PhD","affiliation":"University of Texas","role":"PRINCIPAL_INVESTIGATOR"},{"name":"F. Gerard Moeller, M.D.","affiliation":"University of Texas Medical School at Houston","role":"STUDY_CHAIR"}],"locations":[{"facility":"University of Texas Health Science Center","city":"Houston","state":"Texas","zip":"77030","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"54 were enrolled, but only 51 were randomized and started the study.","groups":[{"id":"FG000","title":"Modafinil 200mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days."},{"id":"FG001","title":"Modafinil 400mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days."},{"id":"FG002","title":"Citalopram 20mg/Methadone Maintenance (1.2mg/kg)","description":"10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days."},{"id":"FG003","title":"Citalopram 40mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days."},{"id":"FG004","title":"Placebo/Methadone Maintenance (1.2mg/kg)","description":"Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"13"},{"groupId":"FG003","numSubjects":"12"},{"groupId":"FG004","numSubjects":"9"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"6"},{"groupId":"FG004","numSubjects":"3"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"6"},{"groupId":"FG004","numSubjects":"6"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Modafinil 200mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days."},{"id":"BG001","title":"Modafinil 400mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days."},{"id":"BG002","title":"Citalopram 20mg/Methadone Maintenance (1.2mg/kg)","description":"10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days."},{"id":"BG003","title":"Citalopram 40mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days."},{"id":"BG004","title":"Placebo/Methadone Maintenance (1.2mg/kg)","description":"Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg"},{"id":"BG005","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"12"},{"groupId":"BG004","value":"9"},{"groupId":"BG005","value":"51"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"36.364","spread":"11.474"},{"groupId":"BG001","value":"40.333","spread":"8.335"},{"groupId":"BG002","value":"38.769","spread":"7.350"},{"groupId":"BG003","value":"36.500","spread":"9.050"},{"groupId":"BG004","value":"36.556","spread":"7.618"},{"groupId":"BG005","value":"37.510","spread":"8.941"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"3"},{"groupId":"BG005","value":"15"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"6"},{"groupId":"BG005","value":"36"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"12"},{"groupId":"BG004","value":"9"},{"groupId":"BG005","value":"51"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Confirmed Abstinence From Cocaine","populationDescription":"The trial was terminated when the PI of the study left the institution. Collected data was stored in a database management system that has since become obsolete and is no longer accessible by current database programs.","reportingStatus":"POSTED","timeFrame":"12 weeks of treatment","groups":[{"id":"OG000","title":"Modafinil 200mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days."},{"id":"OG001","title":"Modafinil 400mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days."},{"id":"OG002","title":"Citalopram 20mg/Methadone Maintenance (1.2mg/kg)","description":"10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days."},{"id":"OG003","title":"Citalopram 40mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days."},{"id":"OG004","title":"Placebo/Methadone Maintenance (1.2mg/kg)","description":"Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}]},{"type":"SECONDARY","title":"Retention","populationDescription":"The trial was terminated when the PI of the study left the institution. Collected data was stored in a database management system that has since become obsolete and is no longer accessible by current database programs.","reportingStatus":"POSTED","timeFrame":"12 weeks of treatment","groups":[{"id":"OG000","title":"Modafinil 200mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days."},{"id":"OG001","title":"Modafinil 400mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days."},{"id":"OG002","title":"Citalopram 20mg/Methadone Maintenance (1.2mg/kg)","description":"10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days."},{"id":"OG003","title":"Citalopram 40mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days."},{"id":"OG004","title":"Placebo/Methadone Maintenance (1.2mg/kg)","description":"Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}]},{"type":"SECONDARY","title":"Medication Compliance","populationDescription":"The trial was terminated when the PI of the study left the institution. Collected data was stored in a database management system that has since become obsolete and is no longer accessible by current database programs.","reportingStatus":"POSTED","timeFrame":"12 weeks of treatment","groups":[{"id":"OG000","title":"Modafinil 200mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days."},{"id":"OG001","title":"Modafinil 400mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days."},{"id":"OG002","title":"Citalopram 20mg/Methadone Maintenance (1.2mg/kg)","description":"10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days."},{"id":"OG003","title":"Citalopram 40mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days."},{"id":"OG004","title":"Placebo/Methadone Maintenance (1.2mg/kg)","description":"Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","description":"The trial was terminated when the PI of the study left the institution. Collected data was stored in a database management system that has since become obsolete and is no longer accessible by current database programs.","eventGroups":[{"id":"EG000","title":"Modafinil 200mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.","deathsNumAffected":0,"deathsNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"otherNumAffected":0,"otherNumAtRisk":0},{"id":"EG001","title":"Modafinil 400mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.","deathsNumAffected":0,"deathsNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"otherNumAffected":0,"otherNumAtRisk":0},{"id":"EG002","title":"Citalopram 20mg/Methadone Maintenance (1.2mg/kg)","description":"10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days.","deathsNumAffected":0,"deathsNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"otherNumAffected":0,"otherNumAtRisk":0},{"id":"EG003","title":"Citalopram 40mg/Methadone Maintenance (1.2mg/kg)","description":"10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days.","deathsNumAffected":0,"deathsNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"otherNumAffected":0,"otherNumAtRisk":0},{"id":"EG004","title":"Placebo/Methadone Maintenance (1.2mg/kg)","description":"Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg","deathsNumAffected":0,"deathsNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"otherNumAffected":0,"otherNumAtRisk":0}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Difficulty recruiting and lower than desired sample size."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Joy M Schmitz, PhD","organization":"The University of Texas Health Science Center at Houston","email":"Joy.M.Schmitz@uth.tmc.edu","phone":"(713) 486-2867"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D019970","term":"Cocaine-Related Disorders"},{"id":"D009293","term":"Opioid-Related Disorders"}],"ancestors":[{"id":"D019966","term":"Substance-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D000079524","term":"Narcotic-Related Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D000077408","term":"Modafinil"},{"id":"D015283","term":"Citalopram"}],"ancestors":[{"id":"D001559","term":"Benzhydryl Compounds"},{"id":"D001555","term":"Benzene Derivatives"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D011437","term":"Propylamines"},{"id":"D000588","term":"Amines"},{"id":"D009570","term":"Nitriles"},{"id":"D001572","term":"Benzofurans"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}