{"protocolSection":{"identificationModule":{"nctId":"NCT01270555","nctIdAliases":["NCT01012024"],"orgStudyIdInfo":{"id":"1999-P-009198"},"organization":{"fullName":"Massachusetts General Hospital","class":"OTHER"},"briefTitle":"Efficacy Of Bupropion For Attention Deficit Hyperactivity Disorder (ADHD) In Adults","officialTitle":"Efficacy Of Bupropion SR For Attention Deficit Hyperactivity Disorder (ADHD) In Adults With Recent Past or Current Substance Use Disorders"},"statusModule":{"statusVerifiedDate":"2013-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"1999-05"},"primaryCompletionDateStruct":{"date":"2001-07","type":"ACTUAL"},"studyFirstSubmitDate":"2011-01-03","studyFirstSubmitQcDate":"2011-01-03","studyFirstPostDateStruct":{"date":"2011-01-05","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-01-07","resultsFirstSubmitQcDate":"2011-01-31","resultsFirstPostDateStruct":{"date":"2011-02-25","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-03-04","lastUpdatePostDateStruct":{"date":"2013-03-08","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Timothy Wilens, MD","investigatorTitle":"MD","investigatorAffiliation":"Massachusetts General Hospital"},"leadSponsor":{"name":"Massachusetts General Hospital","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The investigators propose to conduct an open study to evaluate the efficacy and tolerability of Bupropion SR using clinically relevant doses in ADHD adults with a recent history of or current substance use disorders. We hypothesize that Bupropion SR will be effective in treating ADHD in this population."},"conditionsModule":{"conditions":["Attention Deficit Hyperactivity Disorder (ADHD)","Substance Use Disorder (SUD)"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":32,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Bupropion","type":"EXPERIMENTAL","interventionNames":["Drug: Bupropion SR"]}],"interventions":[{"type":"DRUG","name":"Bupropion SR","description":"100mg capsules Initial dosing 100mgSR every morning, to be titrated to 200mgSR twice daily maximum","armGroupLabels":["Bupropion"],"otherNames":["Wellbutrin"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score","description":"Assesses 18 individual criteria symptoms using a severity grid (0 = not present, 3 = severe; overall minimum score = 0, maximum score = 54)","timeFrame":"baseline and six weeks"},{"measure":"Self-reported Weekly Substance Use","description":"Number of subjects who self-report using at least one of illegal drugs or alcohol, at least once in a week.","timeFrame":"baseline and six weeks"}],"secondaryOutcomes":[{"measure":"Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity","description":"CGI-S 1=not ill, 7=extremely ill","timeFrame":"baseline and six weeks"},{"measure":"Clinical Global Impressions (CGI) Scale of ADHD Severity","description":"Global Severity (CGI-S) 1=not ill, 7=extremely ill","timeFrame":"baseline and six weeks"},{"measure":"Hamilton Anxiety Scale (HAM-A)","description":"minimum score (least severe anxiety) = 0, maximum (most severe) = 56","timeFrame":"baseline and six weeks"},{"measure":"Hamilton Depression Scale (HAM-D)","description":"minimum score (least severe depression) = 0, maximum score (most severe) = 84","timeFrame":"baseline and six weeks"},{"measure":"Beck Depression Inventory (BDI)","description":"minimum score (least severe depression) = 0, maximum score (most severe) = 63","timeFrame":"baseline and six weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male and female outpatients 18 years old or older, up to 60 years old.\n* Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.\n* Patients within the past 6 months known to abuse or to be dependent on alcohol or any drug (nicotine addiction not included)\n\nExclusion Criteria:\n\n* Any clinically unstable medical condition\n* Clinically significant abnormal baseline laboratory values\n* Mental retardation (I.Q. \\<75) or Organic brain disorders\n* Seizure disorder\n* Patients with a history or an eating disorder including anorexia or bulimia nervosa\n* Pregnant or nursing females\n* Patients with current bipolar disorder\n* Psychotic disorder of any type\n* Patients on psychotropics known to treat ADHD (i.e. stimulants, tricyclics)\n* Patients receiving psychotherapy known to treat ADHD (i.e. cognitive or cognitive/behavioral psychotherapy)\n* Patients demonstrating active withdrawal from substance abuse","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"60 Years","stdAges":["ADULT"]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Bupropion","description":"Once daily treatment with Bupropion with intention to treat ADHD and SUD."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"32"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"19"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"13"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Bupropion","description":"Once daily treatment with Bupropion with intention to treat ADHD and SUD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"32"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"32"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"32","spread":"8.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"6"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"26"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"32"}]}]}]},{"title":"DSM-IV Attention Deficit Hyperactivity Rating Scale (ADHD RS)","description":"Assesses 18 individual criteria symptoms on a severity grid (0=not present, 3=severe; overall minimum score = 0, maximum score = 54)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"34.1","spread":"8.2"}]}]}]},{"title":"Self-reported Weekly substance use","description":"Participants who self-report using at least one of illegal drugs or alcohol, at least once per week.","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"32"}]}]}]},{"title":"Clinical Global Impressions (CGI) Score for SUD Severity","description":"Global Severity 1=not ill, 7=extremely ill","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.0","spread":"0.9"}]}]}]},{"title":"Clinical Global Impressions (CGI) Score for ADHD Severity","description":"Global Severity 1=not ill, 7=extremely ill","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5.0","spread":"0.7"}]}]}]},{"title":"Hamilton Anxiety Rating Scale (HAM-A)","description":"minimum (least severe anxiety) = 0, maximum (most severe) = 56","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.1","spread":"6.5"}]}]}]},{"title":"Hamilton Depression rating Scale (HAM-D)","description":"minimum (least severe depression) = 0, maximum (most severe) = 84","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.8","spread":"9.1"}]}]}]},{"title":"Beck Depression Inventory (BDI)","description":"minimum (least severe depression) = 0, maximum (most severe) = 63","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.9","spread":"5.9"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score","description":"Assesses 18 individual criteria symptoms using a severity grid (0 = not present, 3 = severe; overall minimum score = 0, maximum score = 54)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"baseline and six weeks","groups":[{"id":"OG000","title":"Bupropion","description":"Once daily treatment with Bupropion with intention to treat ADHD and SUD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"32"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"19.4","spread":"11.4"}]}]}]},{"type":"SECONDARY","title":"Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity","description":"CGI-S 1=not ill, 7=extremely ill","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"baseline and six weeks","groups":[{"id":"OG000","title":"Bupropion","description":"Once daily treatment with Bupropion with intention to treat ADHD and SUD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"32"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.1","spread":"0.8"}]}]}]},{"type":"SECONDARY","title":"Clinical Global Impressions (CGI) Scale of ADHD Severity","description":"Global Severity (CGI-S) 1=not ill, 7=extremely ill","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"baseline and six weeks","groups":[{"id":"OG000","title":"Bupropion","description":"Once daily treatment with Bupropion with intention to treat ADHD and SUD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"32"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.8","spread":"1.1"}]}]}]},{"type":"PRIMARY","title":"Self-reported Weekly Substance Use","description":"Number of subjects who self-report using at least one of illegal drugs or alcohol, at least once in a week.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"baseline and six weeks","groups":[{"id":"OG000","title":"Bupropion","description":"Once daily treatment with Bupropion with intention to treat ADHD and SUD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"18"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}]}]},{"type":"SECONDARY","title":"Hamilton Anxiety Scale (HAM-A)","description":"minimum score (least severe anxiety) = 0, maximum (most severe) = 56","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"baseline and six weeks","groups":[{"id":"OG000","title":"Bupropion","description":"Once daily treatment with Bupropion with intention to treat ADHD and SUD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"32"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.5","spread":"6.9"}]}]}]},{"type":"SECONDARY","title":"Hamilton Depression Scale (HAM-D)","description":"minimum score (least severe depression) = 0, maximum score (most severe) = 84","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"baseline and six weeks","groups":[{"id":"OG000","title":"Bupropion","description":"Once daily treatment with Bupropion with intention to treat ADHD and SUD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"32"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.5","spread":"5.7"}]}]}]},{"type":"SECONDARY","title":"Beck Depression Inventory (BDI)","description":"minimum score (least severe depression) = 0, maximum score (most severe) = 63","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"baseline and six weeks","groups":[{"id":"OG000","title":"Bupropion","description":"Once daily treatment with Bupropion with intention to treat ADHD and SUD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"32"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.7","spread":"5.1"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Bupropion","description":"Once daily treatment with Bupropion with intention to treat ADHD and SUD.","seriousNumAffected":0,"seriousNumAtRisk":32,"otherNumAffected":0,"otherNumAtRisk":32}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Timothy Wilens, MD","organization":"Massachusetts General Hospital","email":"twilens@partners.org","phone":"617-503-1053"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D001289","term":"Attention Deficit Disorder with Hyperactivity"},{"id":"D019966","term":"Substance-Related Disorders"}],"ancestors":[{"id":"D019958","term":"Attention Deficit and Disruptive Behavior Disorders"},{"id":"D065886","term":"Neurodevelopmental Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D016642","term":"Bupropion"}],"ancestors":[{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}