{"protocolSection":{"identificationModule":{"nctId":"NCT01535573","orgStudyIdInfo":{"id":"2P50DA009262-16A1","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2P50DA009262-16A1"},"secondaryIdInfos":[{"id":"2P50DA009262-16A1","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2P50DA009262-16A1"}],"organization":{"fullName":"The University of Texas Health Science Center, Houston","class":"OTHER"},"briefTitle":"Citalopram for Cocaine Dependence","officialTitle":"Clinical Trial of Serotonin Medication Combination in Cocaine Dependence"},"statusModule":{"statusVerifiedDate":"2020-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-12"},"primaryCompletionDateStruct":{"date":"2016-07","type":"ACTUAL"},"completionDateStruct":{"date":"2016-07","type":"ACTUAL"},"studyFirstSubmitDate":"2011-10-24","studyFirstSubmitQcDate":"2012-02-14","studyFirstPostDateStruct":{"date":"2012-02-17","type":"ESTIMATED"},"resultsFirstSubmitDate":"2020-08-13","resultsFirstSubmitQcDate":"2020-08-13","resultsFirstPostDateStruct":{"date":"2020-08-31","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-08-29","lastUpdatePostDateStruct":{"date":"2020-09-16","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR_INVESTIGATOR","investigatorFullName":"Joy Schmitz","investigatorTitle":"Professor , Behavioral Sciences","investigatorAffiliation":"The University of Texas Health Science Center, Houston"},"leadSponsor":{"name":"Joy Schmitz","class":"OTHER"},"collaborators":[{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This is a phase 2 clinical trial of citalopram pharmacotherapy for treatment of cocaine dependence. Using a double-blind, randomized controlled design, eligible cocaine dependent patients will be assigned equally to one of three medication conditions: placebo or the Selective serotonin re-uptake inhibitor (SSRI) agent, citalopram at either 20 mg per day or 40 mg per day. It is hypothesized that citalopram will reduce cocaine use and increase periods of sustained abstinence substantially more than placebo. Performance on a set of behavioral tasks of impulsivity will be analyzed as potential predictors of treatment response."},"conditionsModule":{"conditions":["Cocaine Dependence"],"keywords":["Cocaine","citalopram","treatment","serotonin"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":108,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Citalopram low dose","type":"ACTIVE_COMPARATOR","description":"Citalopram 20 mg","interventionNames":["Drug: Citalopram"]},{"label":"Citalopram high dose","type":"ACTIVE_COMPARATOR","description":"Citalopram 40 mg","interventionNames":["Drug: Citalopram"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Citalopram","description":"20 mg once per day for 9 weeks","armGroupLabels":["Citalopram low dose"]},{"type":"DRUG","name":"Citalopram","description":"40 mg per day for 9 weeks","armGroupLabels":["Citalopram high dose"]},{"type":"DRUG","name":"Placebo","description":"0 mg per day for 9 weeks","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test","description":"Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use.","timeFrame":"9 weeks"}],"secondaryOutcomes":[{"measure":"Proportion of Cocaine-positive Urines Per Week","description":"Mean proportion of cocaine-positive urines per week, averaged across 9 weeks, is reported. Urine was collected three times each week over 9 weeks. Missing data is imputed as cocaine use.","timeFrame":"9 weeks"},{"measure":"Number of Participants With Cocaine-negative Urines Collected During Treatment Period","description":"Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use.","timeFrame":"9 weeks"},{"measure":"Retention as Assessed by Number of Participants Remaining in Treatment","timeFrame":"9 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* between 18 and 60 years of age\n* meet Diagnostic and Statistical Manual 4 (DSM-IV) criteria for current cocaine dependence\n* be in acceptable health on the basis of interview, medical history and physical exam\n* able to provide the names of at least 2 persons who can generally locate their whereabouts.\n\nExclusion Criteria:\n\n* diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or nicotine\n* have a psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe\n* medical conditions contraindicating citalopram pharmacotherapy\n* taking medications known to have significant drug interactions with the study medication\n* pregnant or nursing for female patients\n* having plans to leave the immediate geographical area within 3 months","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"60 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Joy M Schmitz, Ph.D.","affiliation":"University of Texas at Houston","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"UT-Houston Behavioral and Biomedical Sciences Building","city":"Houston","state":"Texas","zip":"77054","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}}]},"referencesModule":{"references":[{"pmid":"39853194","type":"DERIVED","citation":"de Dios C, Suchting R, Green CE, Webber HE, Moeller FG, Lane SD, Schmitz J. The role of Iowa gambling task performance in response to citalopram treatment for cocaine use disorder. Am J Drug Alcohol Abuse. 2025 Jan 2;51(1):73-84. doi: 10.1080/00952990.2024.2420773. Epub 2025 Jan 24."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Citalopram Low Dose","description":"Citalopram 20 mg\n\nCitalopram: 20 mg once per day for 9 weeks"},{"id":"FG001","title":"Citalopram High Dose","description":"Citalopram 40 mg\n\nCitalopram: 40 mg per day for 9 weeks"},{"id":"FG002","title":"Placebo","description":"Placebo\n\nPlacebo: 0 mg per day for 9 weeks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"44"},{"groupId":"FG002","numSubjects":"43"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"23"},{"groupId":"FG002","numSubjects":"24"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"21"},{"groupId":"FG002","numSubjects":"19"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Citalopram Low Dose","description":"Citalopram 20 mg\n\nCitalopram: 20 mg once per day for 9 weeks"},{"id":"BG001","title":"Citalopram High Dose","description":"Citalopram 40 mg\n\nCitalopram: 40 mg per day for 9 weeks"},{"id":"BG002","title":"Placebo","description":"Placebo\n\nPlacebo: 0 mg per day for 9 weeks"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"44"},{"groupId":"BG002","value":"43"},{"groupId":"BG003","value":"108"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46.905","spread":"7.578"},{"groupId":"BG001","value":"44.477","spread":"9.488"},{"groupId":"BG002","value":"47.116","spread":"8.724"},{"groupId":"BG003","value":"46.000","spread":"8.846"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"19"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"36"},{"groupId":"BG002","value":"35"},{"groupId":"BG003","value":"89"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"American Indian or Alaskan Native","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]}]},{"title":"Black or African American","categories":[{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"31"},{"groupId":"BG003","value":"81"}]}]},{"title":"Hispanic","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"12"}]}]},{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"14"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"44"},{"groupId":"BG002","value":"43"},{"groupId":"BG003","value":"108"}]}]}]},{"title":"Number of Years of Education","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"12.571","spread":"2.216"},{"groupId":"BG001","value":"12.045","spread":"1.796"},{"groupId":"BG002","value":"12.488","spread":"1.921"},{"groupId":"BG003","value":"12.324","spread":"1.932"}]}]}]},{"title":"Number of Days of Cocaine Use in Past 30 Days","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"days","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"12.238","spread":"2.216"},{"groupId":"BG001","value":"17.114","spread":"9.163"},{"groupId":"BG002","value":"14.465","spread":"9.815"},{"groupId":"BG003","value":"15.111","spread":"8.594"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test","description":"Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. 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