{"protocolSection":{"identificationModule":{"nctId":"NCT00253890","orgStudyIdInfo":{"id":"R01DA020479","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DA020479"},"secondaryIdInfos":[{"id":"R01DA020479-01","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DA020479-01"}],"organization":{"fullName":"Butler Hospital","class":"OTHER"},"briefTitle":"Insomnia and Drug Relapse Risk","officialTitle":"Insomnia and Drug Relapse Risk"},"statusModule":{"statusVerifiedDate":"2013-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2005-10"},"primaryCompletionDateStruct":{"date":"2010-05","type":"ACTUAL"},"completionDateStruct":{"date":"2010-05","type":"ACTUAL"},"studyFirstSubmitDate":"2005-11-10","studyFirstSubmitQcDate":"2005-11-14","studyFirstPostDateStruct":{"date":"2005-11-15","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-08-01","resultsFirstSubmitQcDate":"2013-10-22","resultsFirstPostDateStruct":{"date":"2013-12-11","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-10-22","lastUpdatePostDateStruct":{"date":"2013-12-11","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Michael Stein, MD","investigatorTitle":"Director, General Medicine Research","investigatorAffiliation":"Butler Hospital"},"leadSponsor":{"name":"Butler Hospital","class":"OTHER"},"collaborators":[{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purposes of this study are:\n\n1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and\n2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.","detailedDescription":"Individuals new to methadone maintenance will be asked to participate in this 6-month, double-blind, randomized control trial. All participants will complete a baseline interview, a medical screening and follow-up interviews at 1, 3 and 6-months post-baseline. These interviews take approximately 60 minutes, and survey various areas of the participants' experiences, including basic demographic information, mood, sleep and substance use areas. All participants will also be asked to complete a 2-night sleep monitoring at the time of the baseline interview and again at the 1-month follow-up interview. Participants will also receive study medication; half of the participants will receive a placebo medication, and the other half will receive Trazodone, a widely-prescribed, well-tolerated, low side-effect medication. Neither the participant nor the study staff will know which medication the participant is taking while the participant is actively enrolled in the study. This information can be available to the participant at the end of his/her study participation."},"conditionsModule":{"conditions":["Poor Quality Sleep","Opiate Addiction"],"keywords":["sleep quality","methadone","substance use"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":137,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Trazodone","type":"ACTIVE_COMPARATOR","description":"50-150mg (50mg capsules) at bedtime for 90 days","interventionNames":["Drug: Trazodone"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"1-3 capsules at bedtime for 90 days","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Trazodone","description":"50 mg 1-3 capsules at bedtime for 3 months","armGroupLabels":["Trazodone"],"otherNames":["Desyrel","Oleptro","Beneficat","Deprax","Desirel","Molipaxin","Thombran","Trazorel","Trialodine","Trittico","Mesyrel"]},{"type":"DRUG","name":"Placebo","description":"1-3 at bedtime","armGroupLabels":["Placebo"],"otherNames":["Sugar pill"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Sleep Quality, as Measured by Total Sleep Time","description":"Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.","timeFrame":"Baseline to 1-month"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Recent methadone maintenance enrollment\n* Sleep complaints as measured by the Pittsburgh Sleep Quality Index (PSQI)\n* No medical contraindications to trazodone\n\nExclusion Criteria:\n\n* Methadone maintenance enrollment not recent\n* No sleep complaints as measured by the PSQI\n* Medical contraindications to trazodone","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Michael D Stein, MD","affiliation":"Rhode Island Hospital","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Rogers Griffith, MD","affiliation":"The Miriam Hospital","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Butler Hospital","city":"Providence","state":"Rhode Island","zip":"02906","country":"United States","geoPoint":{"lat":41.82399,"lon":-71.41283}}]},"referencesModule":{"references":[{"pmid":"20155590","type":"DERIVED","citation":"Kurth ME, Sharkey KM, Millman RP, Corso RP, Stein MD. Insomnia among methadone-maintained individuals: the feasibility of collecting home polysomnographic recordings. J Addict Dis. 2009 Jul;28(3):219-25. doi: 10.1080/10550880903014155."}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Participants were recruited from 8 methadone maintenance clinics in the Providence, RI area.","groups":[{"id":"FG000","title":"Trazodone","description":"50-150mg at bedtime"},{"id":"FG001","title":"Placebo","description":"1-3 capsules at bedtime"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"69"},{"groupId":"FG001","numSubjects":"68"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"62"},{"groupId":"FG001","numSubjects":"61"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"7"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Trazodone","description":"50-150mg at bedtime"},{"id":"BG001","title":"Placebo","description":"1-3 at bedtime"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"69"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"137"}]}],"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":"69"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"137"}]},{"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":"38.0","spread":"8.8"},{"groupId":"BG001","value":"38.5","spread":"8.7"},{"groupId":"BG002","value":"38.2","spread":"8.6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"73"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"35"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"64"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"69"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"137"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Sleep Quality, as Measured by Total Sleep Time","description":"Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.","populationDescription":"Intent to Treat","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"minutes","timeFrame":"Baseline to 1-month","groups":[{"id":"OG000","title":"Trazodone","description":"50-150mg at bedtime"},{"id":"OG001","title":"Placebo","description":"1-3 capsules at bedtime"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"67"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"339","spread":"136"},{"groupId":"OG001","value":"329","spread":"124"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Change in sleep quality was assessed by calculating gain scores. We used a 2-sided t-test to report mean change.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".05","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Net)","paramValue":"35.7","ciPctValue":"95"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","eventGroups":[{"id":"EG000","title":"Trazodone","description":"50-150mg at bedtime","seriousNumAffected":0,"seriousNumAtRisk":69,"otherNumAffected":0,"otherNumAtRisk":69},{"id":"EG001","title":"Placebo","description":"1-3 at bedtime","seriousNumAffected":0,"seriousNumAtRisk":68,"otherNumAffected":0,"otherNumAtRisk":68}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Michael D. Stein, MD","organization":"Butler Hospital","email":"mstein@butler.org","phone":"401-455-6646"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D009293","term":"Opioid-Related Disorders"},{"id":"D007319","term":"Sleep Initiation and Maintenance Disorders"},{"id":"D019966","term":"Substance-Related Disorders"}],"ancestors":[{"id":"D000079524","term":"Narcotic-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D020919","term":"Sleep Disorders, Intrinsic"},{"id":"D020920","term":"Dyssomnias"},{"id":"D012893","term":"Sleep Wake Disorders"},{"id":"D009422","term":"Nervous System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D014196","term":"Trazodone"},{"id":"D000073893","term":"Sugars"}],"ancestors":[{"id":"D010879","term":"Piperazines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D011728","term":"Pyridones"},{"id":"D011725","term":"Pyridines"},{"id":"D002241","term":"Carbohydrates"}]}},"hasResults":true}