{"protocolSection":{"identificationModule":{"nctId":"NCT02265367","orgStudyIdInfo":{"id":"1409M53561"},"organization":{"fullName":"University of Minnesota","class":"OTHER"},"briefTitle":"Novel Medication as a Potential Smoking Cessation Aid","officialTitle":"Novel Medication as a Potential Smoking Cessation Aid"},"statusModule":{"statusVerifiedDate":"2022-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2015-01"},"primaryCompletionDateStruct":{"date":"2017-05","type":"ACTUAL"},"completionDateStruct":{"date":"2017-05","type":"ACTUAL"},"studyFirstSubmitDate":"2014-10-09","studyFirstSubmitQcDate":"2014-10-09","studyFirstPostDateStruct":{"date":"2014-10-15","type":"ESTIMATED"},"resultsFirstSubmitDate":"2022-03-28","resultsFirstSubmitQcDate":"2022-03-28","resultsFirstPostDateStruct":{"date":"2022-04-22","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-03-28","lastUpdatePostDateStruct":{"date":"2022-04-22","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Minnesota","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to provide preliminary information assessing if levomilnacipran may be effective at increasing smoking cessation rates."},"conditionsModule":{"conditions":["Tobacco Use Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"OTHER","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":56,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Levomilnacipran","type":"EXPERIMENTAL","description":"In the first three week period levomilnacipran is evaluated whereas in the second three week period placebo is evaluated","interventionNames":["Drug: Levomilnacipran","Drug: Placebo"]},{"label":"Placebo","type":"EXPERIMENTAL","description":"In the first three week period placebo is evaluated whereas in the second three week period levomilnacipran is evaluated","interventionNames":["Drug: Levomilnacipran","Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Levomilnacipran","armGroupLabels":["Levomilnacipran","Placebo"],"otherNames":["Fetzima"]},{"type":"DRUG","name":"Placebo","armGroupLabels":["Levomilnacipran","Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percent of Days of Confirmed Abstinence (Out of 5 Maximum)","description":"Subjects will be asked to abstain for five consecutive days during the third week of each intervention period with the percentage of confirmed abstinence days being the primary outcome measure","timeFrame":"5 days"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Be between 25 years old and 55 years old\n* Smoke a minimum number of cigarettes per day\n* Indicate motivation to quit smoking\n\nExclusion Criteria:\n\n* Current or history of medical or psychiatric conditions that could interfere with measures being studied or that could be affected by the study medication\n* Use of medication that could interfere with measures to be studied or that could be expected to interact with levomilnacipran\n* Are pregnant or breast feeding\n\nThe investigators will evaluate if there are other reasons why someone may not be eligible to participate","healthyVolunteers":false,"sex":"ALL","minimumAge":"25 Years","maximumAge":"55 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Michael Kotlyar, PharmD","affiliation":"University of Minnesota","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Clinical and Translational Sciences Institute","city":"Minneapolis","state":"Minnesota","zip":"55455","country":"United States","geoPoint":{"lat":44.97997,"lon":-93.26384}}]},"ipdSharingStatementModule":{"ipdSharing":"UNDECIDED"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Levomilnacipran Then Placebo","description":"In the first three week period, baseline measures are obtained during the first week, levomilnacipran started during the second week and effects on smoking behavior assessed during the third week. For the subsequent three-week period, washout occurs during the first week, placebo is started during the second week and effects on smoking behavior assessed during the third week."},{"id":"FG001","title":"Placebo Then Levomilnacipran","description":"In the first three week period, baseline measures are obtained during the first week, placebo started during the second week and effects on smoking behavior assessed during the third week. For the subsequent three-week period, washout occurs during the first week, levomilnacipran is started during the second week and effects on smoking behavior assessed during the third week.\n\nPlacebo"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"28"}]},{"type":"Completed First 3-week Period","achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"26"}]},{"type":"COMPLETED","comment":"Completer defined as participants who completed at least 2 of the 5 assessments occurring during the third week of each three-week period.","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"22"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"6"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Levomilnacipran Then Placebo","description":"In the first three week period, baseline measures are obtained during the first week, levomilnacipran started during the second week and effects on smoking behavior assessed during the third week. For the subsequent three-week period, washout occurs during the first week, placebo is started during the second week and effects on smoking behavior assessed during the third week."},{"id":"BG001","title":"Placebo Then Levomilnacipran","description":"In the first three week period, baseline measures are obtained during the first week, placebo started during the second week and effects on smoking behavior assessed during the third week. For the subsequent three-week period, washout occurs during the first week, levomilnacipran is started during the second week and effects on smoking behavior assessed during the third week."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"56"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"45","lowerLimit":"28","upperLimit":"55"},{"groupId":"BG001","value":"44","lowerLimit":"26","upperLimit":"55"},{"groupId":"BG002","value":"44","lowerLimit":"26","upperLimit":"55"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"16"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"40"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"51"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"20"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"30"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"56"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Percent of Days of Confirmed Abstinence (Out of 5 Maximum)","description":"Subjects will be asked to abstain for five consecutive days during the third week of each intervention period with the percentage of confirmed abstinence days being the primary outcome measure","populationDescription":"Only participants who completed the study were analyzed. Completers were those with data from at least 2 days during the third week of the second three week period","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of days non-smoking","timeFrame":"5 days","groups":[{"id":"OG000","title":"Levomilnacipran","description":"In this three week period, baseline measures are obtained during the first week, levomilnacipran started during the second week and effects on smoking behavior assessed during the third week."},{"id":"OG001","title":"Placebo","description":"In this three week period, baseline measures are obtained during the first week, placebo during the second week and effects on smoking behavior during the third week"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"46.9","spread":"6.7"},{"groupId":"OG001","value":"42.0","spread":"6.5"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo","description":"Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication","eventGroups":[{"id":"EG000","title":"Levomilnacipran","description":"In this three week period, baseline measures are obtained during the first week, levomilnacipran will be started during the second week and effects on smoking behavior will be assessed during the third week\n\nLevomilnacipran","deathsNumAffected":0,"deathsNumAtRisk":52,"seriousNumAffected":0,"seriousNumAtRisk":52,"otherNumAffected":37,"otherNumAtRisk":52},{"id":"EG001","title":"Placebo","description":"In this three week period, baseline measures are obtained during the first week, placebo will be started during the second week and effects on smoking behavior will be assessed during the third week\n\nPlacebo","deathsNumAffected":0,"deathsNumAtRisk":51,"seriousNumAffected":0,"seriousNumAtRisk":51,"otherNumAffected":26,"otherNumAtRisk":51}],"otherEvents":[{"term":"Sleep / Energy Changes","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":52},{"groupId":"EG001","numAffected":12,"numAtRisk":51}]},{"term":"Gastrointestinal Symptoms","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":52},{"groupId":"EG001","numAffected":10,"numAtRisk":51}]},{"term":"Headache","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":52},{"groupId":"EG001","numAffected":8,"numAtRisk":51}]},{"term":"Changes in Mood, Anxiety or Irritability Level","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":52},{"groupId":"EG001","numAffected":2,"numAtRisk":51}]},{"term":"Dizziness","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52},{"groupId":"EG001","numAffected":5,"numAtRisk":51}]},{"term":"Excessive Sweating","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52},{"groupId":"EG001","numAffected":3,"numAtRisk":51}]},{"term":"Body aches / pains","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52},{"groupId":"EG001","numAffected":2,"numAtRisk":51}]},{"term":"Dry mouth","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52},{"groupId":"EG001","numAffected":2,"numAtRisk":51}]},{"term":"Change in Appetite","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52},{"groupId":"EG001","numAffected":2,"numAtRisk":51}]},{"term":"Cold / Seasonal Allergy Symptoms","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":52},{"groupId":"EG001","numAffected":3,"numAtRisk":51}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Michael Kotlyar","organization":"University of Minnesota","email":"kotly001@umn.edu","phone":"612-625-1160"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2016-02-26","uploadDate":"2022-03-25T17:22","filename":"Prot_SAP_000.pdf","size":190456}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D014029","term":"Tobacco Use Disorder"}],"ancestors":[{"id":"D019966","term":"Substance-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D000078862","term":"Levomilnacipran"}],"ancestors":[{"id":"D000078764","term":"Milnacipran"},{"id":"D003521","term":"Cyclopropanes"},{"id":"D003516","term":"Cycloparaffins"},{"id":"D006840","term":"Hydrocarbons, Alicyclic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}