{"protocolSection":{"identificationModule":{"nctId":"NCT00687713","orgStudyIdInfo":{"id":"MDS Bupropion Meth 0001"},"organization":{"fullName":"National Institute on Drug Abuse (NIDA)","class":"NIH"},"briefTitle":"Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence","officialTitle":"Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence"},"statusModule":{"statusVerifiedDate":"2017-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-05"},"primaryCompletionDateStruct":{"date":"2011-05","type":"ACTUAL"},"completionDateStruct":{"date":"2011-05","type":"ACTUAL"},"studyFirstSubmitDate":"2008-05-29","studyFirstSubmitQcDate":"2008-05-29","studyFirstPostDateStruct":{"date":"2008-06-02","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-12-22","resultsFirstSubmitQcDate":"2016-12-22","resultsFirstPostDateStruct":{"date":"2017-02-15","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-02-14","lastUpdatePostDateStruct":{"date":"2017-03-21","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to the start of signing consent.","detailedDescription":"The primary objective of this study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to signing consent. Secondary objectives included but were not limited to: assessing the success or failure to achieve abstinence (confirmed by at least two methamphetaminenegative urines and no methamphetamine-positive urines) each week during the last two weeks (Weeks 11 and 12) for subjects using methamphetamine 18 or less days during the 30 days prior to signing consent, assessing the safety of bupropion in this study population, assessing other measures of efficacy of bupropion in reducing methamphetamine use or craving, and other psychological assessments of methamphetamine dependence.\n\nIt is hypothesized that bupropion, compared to placebo, would be associated with an increase in the proportion of subjects who achieved abstinence (confirmed by at least two methamphetamine-negative urines and no methamphetaminepositive urines) each week during the last two weeks (Weeks 11 and 12) for non-daily users."},"conditionsModule":{"conditions":["Methamphetamine Dependence"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":200,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Bupropion","type":"ACTIVE_COMPARATOR","description":"Subjects will receive bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.","interventionNames":["Drug: Bupropion"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Subjects will receive a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.","interventionNames":["Other: Placebo"]}],"interventions":[{"type":"DRUG","name":"Bupropion","description":"150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.","armGroupLabels":["Bupropion"]},{"type":"OTHER","name":"Placebo","description":"Placebo","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Subjects Showing Abstinence","description":"The primary efficacy outcome measure was a measurement of treatment success or failure, where a subject who successfully achieved two weeks of abstinence during the last two weeks of investigational product dosing (Weeks 11 and 12) was scored as a success.","timeFrame":"Weeks 11 and 12"}],"secondaryOutcomes":[{"measure":"Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use","description":"The study population for this outcome measure is defined as those participants with methamphetamine dependence who report using methamphetamine 18 or less days during the 30 days prior to signing consent.","timeFrame":"30 days"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Must have a DSM-IV diagnosis of methamphetamine dependence as determined by MINI\n* Must have at least 1 amphetamine or methamphetamine positive urine specimen after the start of screening and before randomization or provide information to verify recent use if a positive urine sample can't be obtained\n* Must report using methamphetamine for 29 days or less during the 30 day period prior signing consent using the timeline follow-back method\n* Must be willing and able to comply with study procedures\n* Must be able to verbalize and understand consent forms and provide written informed consent\n* Must be seeking treatment for methamphetamine dependence\n\nExclusion Criteria:\n\n* Please contact study site for more information","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Jurij Mojsiak","affiliation":"National Institute on Drug Abuse (NIDA)","role":"STUDY_CHAIR"}],"locations":[{"facility":"UCLA Integrated Substance Abuse Program","city":"Los Angeles","state":"California","zip":"90025","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"South Bay Treatment Center","city":"San Diego","state":"California","zip":"92115","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Addiction and Pharmacology Research Laboratory","city":"San Francisco","state":"California","zip":"94110","country":"United States","geoPoint":{"lat":37.77493,"lon":-122.41942}},{"facility":"Friends Research Institute","city":"Torrance","state":"California","zip":"90502","country":"United States","geoPoint":{"lat":33.83585,"lon":-118.34063}},{"facility":"Matrix Institute","city":"Woodland Hills","state":"California","zip":"91364","country":"United States","geoPoint":{"lat":34.16834,"lon":-118.60592}},{"facility":"Pacific Addiction Research Center - U of Hawaii","city":"Honolulu","state":"Hawaii","zip":"96817","country":"United States","geoPoint":{"lat":21.30694,"lon":-157.85833}},{"facility":"Iowa Luther Hospital","city":"Des Moines","state":"Iowa","zip":"50316","country":"United States","geoPoint":{"lat":41.60054,"lon":-93.60911}},{"facility":"U of Kansas Medical Center","city":"Kansas City","state":"Missouri","zip":"64131","country":"United States","geoPoint":{"lat":39.09973,"lon":-94.57857}},{"facility":"New York University","city":"New York","state":"New York","zip":"10010","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","zip":"29425","country":"United States","geoPoint":{"lat":32.77632,"lon":-79.93275}},{"facility":"University of Texas Health Science At San Antonio","city":"San Antonio","state":"Texas","zip":"78229-3900","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"VA Salt Lake City Health Care System","city":"Salt Lake City","state":"Utah","zip":"84148","country":"United States","geoPoint":{"lat":40.76078,"lon":-111.89105}}]},"referencesModule":{"references":[{"pmid":"25818061","type":"BACKGROUND","citation":"Anderson AL, Li SH, Markova D, Holmes TH, Chiang N, Kahn R, Campbell J, Dickerson DL, Galloway GP, Haning W, Roache JD, Stock C, Elkashef AM. Bupropion for the treatment of methamphetamine dependence in non-daily users: a randomized, double-blind, placebo-controlled trial. Drug Alcohol Depend. 2015 May 1;150:170-4. doi: 10.1016/j.drugalcdep.2015.01.036. Epub 2015 Feb 7."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Bupropion","description":"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.\n\nBupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."},{"id":"FG001","title":"Placebo","description":"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.\n\nPlacebo: Placebo"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"100"},{"groupId":"FG001","numSubjects":"104"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"68"},{"groupId":"FG001","numSubjects":"64"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"40"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Bupropion","description":"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.\n\nBupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."},{"id":"BG001","title":"Placebo","description":"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.\n\nPlacebo: Placebo"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"100"},{"groupId":"BG001","value":"104"},{"groupId":"BG002","value":"204"}]}],"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":"100"},{"groupId":"BG001","value":"104"},{"groupId":"BG002","value":"204"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"72"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"63"},{"groupId":"BG001","value":"69"},{"groupId":"BG002","value":"132"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"100"},{"groupId":"BG001","value":"105"},{"groupId":"BG002","value":"205"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Subjects Showing Abstinence","description":"The primary efficacy outcome measure was a measurement of treatment success or failure, where a subject who successfully achieved two weeks of abstinence during the last two weeks of investigational product dosing (Weeks 11 and 12) was scored as a success.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Weeks 11 and 12","groups":[{"id":"OG000","title":"Bupropion","description":"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.\n\nBupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."},{"id":"OG001","title":"Placebo","description":"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.\n\nPlacebo: Placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"104"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"20"}]}]}]},{"type":"SECONDARY","title":"Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use","description":"The study population for this outcome measure is defined as those participants with methamphetamine dependence who report using methamphetamine 18 or less days during the 30 days prior to signing consent.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"30 days","groups":[{"id":"OG000","title":"Bupropion","description":"Subjects will receive bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.\n\nBupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."},{"id":"OG001","title":"Placebo","description":"Subjects will receive a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.\n\nPlacebo: Placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"104"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"76"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"2","eventGroups":[{"id":"EG000","title":"Bupropion","description":"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.\n\nBupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.","seriousNumAffected":1,"seriousNumAtRisk":100,"otherNumAffected":83,"otherNumAtRisk":100},{"id":"EG001","title":"Placebo","description":"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.\n\nPlacebo: Placebo","seriousNumAffected":3,"seriousNumAtRisk":104,"otherNumAffected":93,"otherNumAtRisk":104}],"seriousEvents":[{"term":"Gastric bypass","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Subject underwent elective gastric bypass surgery without complication. Was hospitalized and discharged 3 days later. Severity was moderate. Event was unexpected and definitely not related to study drug. She is recovered and continued in the study.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":100},{"groupId":"EG001","numAffected":3,"numAtRisk":104}]}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":14,"numAffected":9,"numAtRisk":100},{"groupId":"EG001","numEvents":27,"numAffected":23,"numAtRisk":104}]},{"term":"Headache","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":68,"numAffected":37,"numAtRisk":100},{"groupId":"EG001","numEvents":88,"numAffected":43,"numAtRisk":104}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":4,"numAtRisk":100},{"groupId":"EG001","numEvents":12,"numAffected":12,"numAtRisk":104}]},{"term":"Back Pain","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":19,"numAffected":18,"numAtRisk":100},{"groupId":"EG001","numEvents":13,"numAffected":11,"numAtRisk":104}]},{"term":"Cough","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":17,"numAffected":16,"numAtRisk":100},{"groupId":"EG001","numEvents":17,"numAffected":14,"numAtRisk":104}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Ann Anderson, MD","organization":"National Institute on Drug Abuse","email":"aanderso@nida.nih.gov","phone":"301-827-5916"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"interventionBrowseModule":{"meshes":[{"id":"D016642","term":"Bupropion"}],"ancestors":[{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}