{"protocolSection":{"identificationModule":{"nctId":"NCT00475878","orgStudyIdInfo":{"id":"DA022207"},"secondaryIdInfos":[{"id":"0807-002"}],"organization":{"fullName":"Butler Hospital","class":"OTHER"},"briefTitle":"SSRI and Buprenorphine","officialTitle":"Antidepressants During Office-Based Buprenorphine"},"statusModule":{"statusVerifiedDate":"2012-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-12"},"primaryCompletionDateStruct":{"date":"2009-09","type":"ACTUAL"},"completionDateStruct":{"date":"2009-09","type":"ACTUAL"},"studyFirstSubmitDate":"2007-05-18","studyFirstSubmitQcDate":"2007-05-18","studyFirstPostDateStruct":{"date":"2007-05-21","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-06-28","resultsFirstSubmitQcDate":"2012-03-05","resultsFirstPostDateStruct":{"date":"2012-04-03","type":"ESTIMATED"},"lastUpdateSubmitDate":"2012-03-05","lastUpdatePostDateStruct":{"date":"2012-04-03","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Michael Stein, MD","investigatorTitle":"Principal Investigator","investigatorAffiliation":"Butler Hospital"},"leadSponsor":{"name":"Butler Hospital","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study is designed to test whether treatment of depressive symptoms using escitalopram improves adherence to Buprenorphine and reduces symptoms of depression for individuals receiving Buprenorphine through their medical provider.","detailedDescription":"Participants interested in receiving Buprenorphine will be offered the opportunity to enroll in this study. Enrolled study participants will complete interviews at baseline and again every two weeks for a total of 8 interviews over 3 months. In this double-blind randomized controlled trial, participants will either receive a placebo or escitalopram (10mg). All participants will also be followed by their Buprenorphine clinic medical provider. Questions during the face-to-face interviews will assess mood, drug craving, pain, sleep, medication adherence and drug-related experiences. Comparison(s): Participants randomized into the medication component of the study as compared to participants randomized into the placebo component of the study."},"conditionsModule":{"conditions":["Opiate Dependence","Depression"],"keywords":["opiate use","depression","buprenorphine","escitalopram"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":147,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]},{"label":"escitalopram","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: escitalopram"]}],"interventions":[{"type":"DRUG","name":"escitalopram","description":"10mg escitalopram/day for 3 months","armGroupLabels":["escitalopram"]},{"type":"DRUG","name":"placebo","description":"placebo capsule/day for 3 months","armGroupLabels":["placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percentage of Participants Who Dropped Out of Buprenorphine Treatment","description":"Drop-out is defined as 7 or more days of missed Buprenorphine doses","timeFrame":"3 months"}],"secondaryOutcomes":[{"measure":"Depressive Symptoms","description":"Depressive symptoms, as measured by self-report during study interviews, using the Beck Depression Inventory II. Scores ranged from 0-63; higher scores indicate more depressive symptoms.","timeFrame":"3 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* opiate dependence\n* Ham-D \\> 14\n\nExclusion Criteria:\n\n* no psychiatric contraindications to using escitalopram\n* no medical contraindications to using escitalopram\n* methadone dose \\< 30\n* no current SSRI use","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Michael D Stein, M.D.","affiliation":"Rhode Island Hospital","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Butler Hospital","city":"Providence","state":"Rhode Island","zip":"02906","country":"United States","geoPoint":{"lat":41.82399,"lon":-71.41283}}]},"referencesModule":{"references":[{"pmid":"24521036","type":"DERIVED","citation":"Tsui JI, Anderson BJ, Strong DR, Stein MD. Craving predicts opioid use in opioid-dependent patients initiating buprenorphine treatment: a longitudinal study. Am J Drug Alcohol Abuse. 2014 Mar;40(2):163-9. doi: 10.3109/00952990.2013.848875. Epub 2014 Feb 12."},{"pmid":"23891461","type":"DERIVED","citation":"Cioe PA, Anderson BJ, Stein MD. Change in symptoms of erectile dysfunction in depressed men initiating buprenorphine therapy. J Subst Abuse Treat. 2013 Nov-Dec;45(5):451-6. doi: 10.1016/j.jsat.2013.06.004. Epub 2013 Jul 23."},{"pmid":"22864399","type":"DERIVED","citation":"Strong DR, Brown RA, Sims M, Herman DS, Anderson BJ, Stein MD. Persistence on a stress-challenge task before initiating buprenorphine treatment was associated with successful transition from opioid use to early abstinence. J Addict Med. 2012 Sep;6(3):219-25. doi: 10.1097/ADM.0b013e31825d927f."},{"pmid":"21924552","type":"DERIVED","citation":"Tsui JI, Herman DS, Kettavong M, Anderson BJ, Stein MD. Escitalopram is associated with reductions in pain severity and pain interference in opioid dependent patients with depressive symptoms. Pain. 2011 Nov;152(11):2640-2644. doi: 10.1016/j.pain.2011.08.011. Epub 2011 Sep 15."},{"pmid":"21491290","type":"DERIVED","citation":"Tsui JI, Herman DS, Kettavong M, Anderson BJ, Stein MD. Chronic pain and hepatitis C virus infection in opioid dependent injection drug users. J Addict Dis. 2011 Apr;30(2):91-7. doi: 10.1080/10550887.2011.554775."},{"pmid":"20598836","type":"DERIVED","citation":"Stein MD, Herman DS, Kettavong M, Cioe PA, Friedmann PD, Tellioglu T, Anderson BJ. Antidepressant treatment does not improve buprenorphine retention among opioid-dependent persons. J Subst Abuse Treat. 2010 Sep;39(2):157-66. doi: 10.1016/j.jsat.2010.05.014. Epub 2010 Jul 3."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo","description":"placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence"},{"id":"FG001","title":"10 mg Escitalopram","description":"10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"75"},{"groupId":"FG001","numSubjects":"72"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"75"},{"groupId":"FG001","numSubjects":"72"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo","description":"placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence"},{"id":"BG001","title":"10 mg Escitalopram","description":"10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"75"},{"groupId":"BG001","value":"72"},{"groupId":"BG002","value":"147"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"75"},{"groupId":"BG001","value":"72"},{"groupId":"BG002","value":"147"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"36.8","spread":"9.8"},{"groupId":"BG001","value":"38.3","spread":"9.6"},{"groupId":"BG002","value":"37.5","spread":"9.9"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"35"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"57"},{"groupId":"BG001","value":"55"},{"groupId":"BG002","value":"112"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"75"},{"groupId":"BG001","value":"72"},{"groupId":"BG002","value":"147"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Percentage of Participants Who Dropped Out of Buprenorphine Treatment","description":"Drop-out is defined as 7 or more days of missed Buprenorphine doses","populationDescription":"Participants who were fully eligible for the study, completed the enrollment process and began study medication were used in an intent to treat analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"3 months","groups":[{"id":"OG000","title":"10 mg Escitalopram","description":"in a double-blind, randomized controlled trial, participants were given 10mg escitalopram prior to buprenorphine induction"},{"id":"OG001","title":"Placebo","description":"in a double-blind, randomized controlled trial, participants were given placebo prior to buprenorphine induction"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"75"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"33.3"},{"groupId":"OG001","value":"44.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".19","statisticalMethod":"Chi-squared","paramType":"Odds Ratio (OR)","paramValue":".64","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":".33","ciUpperLimit":"1.24","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":".22"}]},{"type":"SECONDARY","title":"Depressive Symptoms","description":"Depressive symptoms, as measured by self-report during study interviews, using the Beck Depression Inventory II. Scores ranged from 0-63; higher scores indicate more depressive symptoms.","populationDescription":"participants who were fully eligible for the study, completed the enrollment process and began study medication were included in an intent to treat analysis","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"3 months","groups":[{"id":"OG000","title":"10 mg Escitalopram","description":"individuals were given 10mg escitalopram prior to buprenorphine induction"},{"id":"OG001","title":"Placebo","description":"individuals were given a placebo study medication prior to buprenorphine induction"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"75"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12.31","spread":"1.79"},{"groupId":"OG001","value":"11.35","spread":"1.46"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".18","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":".96","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.79","ciUpperLimit":"5.84","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.16"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"adverse event information was collected at each study appointment, which occurred every 1-2 weeks throughout participant's 12-week study participation.","description":"adverse event information was collected via structured questionnaires and by the study physician during bi-weekly medication visits.","eventGroups":[{"id":"EG000","title":"Placebo","description":"placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence","seriousNumAffected":1,"seriousNumAtRisk":75,"otherNumAffected":0,"otherNumAtRisk":75},{"id":"EG001","title":"10 mg Escitalopram","description":"10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence","seriousNumAffected":0,"seriousNumAtRisk":72,"otherNumAffected":0,"otherNumAtRisk":72}],"seriousEvents":[{"term":"increasing clinical symptoms","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":75},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":72}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Michael Stein","organization":"Butler Hospital","email":"michael_stein@brown.edu","phone":"401-455-6646"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D009293","term":"Opioid-Related Disorders"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D000079524","term":"Narcotic-Related Disorders"},{"id":"D019966","term":"Substance-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D000089983","term":"Escitalopram"}],"ancestors":[{"id":"D011437","term":"Propylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"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}