{"protocolSection":{"identificationModule":{"nctId":"NCT01926626","orgStudyIdInfo":{"id":"Pro00044174"},"secondaryIdInfos":[{"id":"P50DA027840-01","type":"NIH","link":"https://reporter.nih.gov/quickSearch/P50DA027840-01"}],"organization":{"fullName":"Duke University","class":"OTHER"},"briefTitle":"Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers","officialTitle":"Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers","acronym":"RIMA"},"statusModule":{"statusVerifiedDate":"2017-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-09"},"primaryCompletionDateStruct":{"date":"2014-07","type":"ACTUAL"},"completionDateStruct":{"date":"2014-10","type":"ACTUAL"},"studyFirstSubmitDate":"2013-08-19","studyFirstSubmitQcDate":"2013-08-19","studyFirstPostDateStruct":{"date":"2013-08-21","type":"ESTIMATED"},"resultsFirstSubmitDate":"2015-06-08","resultsFirstSubmitQcDate":"2015-07-01","resultsFirstPostDateStruct":{"date":"2015-07-29","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-08-17","lastUpdatePostDateStruct":{"date":"2017-08-23","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR_INVESTIGATOR","investigatorFullName":"Jed E. Rose","investigatorTitle":"Professor, Department of Psychiatry and Behavioral Sciences","investigatorAffiliation":"Duke University"},"leadSponsor":{"name":"Jed E. Rose","class":"OTHER"},"collaborators":[{"name":"Philip Morris USA, Inc.","class":"INDUSTRY"},{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The proposed study will assess the efficacy of moclobemide, a selective, reversible MAO-A inhibitor, in facilitating smoking cessation in treatment-seeking female smokers. This rationale is based on several findings from previous work: 1) cigarette smoke contains constituents that inhibit both forms of the enzyme monoamine oxidase (MAO-A and MAO-B); 2) that severity of depression symptoms after smoking abstinence is correlated with the level of MAO-A inhibition previously obtained from smoking; 3) moclobemide, an MAO-A inhibitor was found efficacious in a smoking cessation treatment trial (Berlin et al., 1995); and 4) women show a greater association between smoking and depression than men and women smokers in our previous trials report smoking to alleviate symptoms of depression to a greater extent than men."},"conditionsModule":{"conditions":["Nicotine Dependence"],"keywords":["Nicotine addiction","Smoking Cessation","Quit Smoking","moclobemide","Nicotine Patch"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":76,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Nicotine Patch+Moclobemide","type":"EXPERIMENTAL","description":"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.","interventionNames":["Drug: Nicotine Patch","Drug: Moclobemide"]}],"interventions":[{"type":"DRUG","name":"Nicotine Patch","description":"Pre-Quit Period: 2 weeks of patch use (21mg/24hr)\n\nPost Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)","armGroupLabels":["Nicotine Patch+Moclobemide"],"otherNames":["Nicoderm"]},{"type":"DRUG","name":"Moclobemide","description":"Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)\n\nPost Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)","armGroupLabels":["Nicotine Patch+Moclobemide"],"otherNames":["reversible MAO-A inhibitor"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Continuous Four-week Abstinence From Smoking","description":"Number of participants who reported continuous four-week abstinence from smoking (weeks 6-10 post target quit date), confirmed by expired air carbon monoxide (CO).","timeFrame":"Weeks 6-10 post quit day"}],"secondaryOutcomes":[{"measure":"Point Abstinence From Smoking at Six Months Post Quit","description":"Number of participants who reported 7-day point abstinence from smoking at six months post quit, confirmed by expired air CO.","timeFrame":"7 day point abstinence from smoking at six months post quit"},{"measure":"Continuous Ten Week Abstinence From Smoking","description":"Number of participants who reported continuous ten-week abstinence from smoking (weeks 1-10 post quit day), confirmed by expired air CO.","timeFrame":"10 weeks post quit day"},{"measure":"Percentage of Change in Smoking Withdrawal Symptoms","description":"Withdrawal symptoms will be assessed by questionnaire on Quit Day, 1 week post quit, 3 weeks post quit, 6 weeks post quit,10 weeks post quit and 6 months post quit (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.","timeFrame":"Quit day and 1 week, 3 weeks, 6 weeks, 10 weeks and 6 months post quit day"},{"measure":"Percentage of Change in Expired Air Carbon Monoxide (CO) During the First Week of Nicotine Patch Treatment.","description":"The initial response to nicotine patch will be assessed by looking at the percent change in expired air carbon monoxide (CO) at the end of week one (Study Visit 2) relative to baseline (Study Visit 1).","timeFrame":"Baseline and 1 week"}],"otherOutcomes":[{"measure":"Safety of Moclobemide + Nicotine Patch","description":"Safety of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants rating side effects \\> \"moderate\".","timeFrame":"1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch"},{"measure":"Tolerability of Moclobemide + Nicotine Patch","description":"Tolerability of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants requiring dose reductions (or discontinuation of medication).","timeFrame":"1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have no known serious medical conditions;\n* Female;\n* Are 18-65 years old;\n* Smoke an average of at least 20 cigarettes per day;\n* Have smoked at least one cumulative year;\n* Have a Fagerstrom Test for Nicotine Dependence score of at least 5;\n* Have an expired air carbon monoxide (CO) reading of at least 10ppm;\n* Able to read and understand English;\n* Express a desire to quit smoking in the next thirty days.\n\nPotential subjects must agree to avoid the following during their participation in this study:\n\n* excessive alcohol consumption;\n* use of other antidepressants;\n* general anesthesia;\n* participation in any other nicotine-related modification strategy outside of this protocol;\n* use of tobacco products other than cigarettes, including pipe tobacco, cigars, e-cigarettes, snuff, and chewing tobacco;\n* use of experimental (investigational) drugs or devices;\n* use of illegal drugs;\n* cimetidine;\n* Tyramine rich foods;\n* use of opiate medications.\n\nExclusion Criteria:\n\n* Hypertension;\n* Hypotension with symptoms;\n* Coronary heart disease;\n* Lifetime history of heart attack;\n* Cardiac rhythm disorder;\n* Chest pains;\n* Cardiac (heart) disorder;\n* Active skin disorder;\n* Liver or kidney disorder;\n* Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;\n* Active ulcers in the past 30 days;\n* Currently Symptomatic lung disorder/disease;\n* Brain abnormality;\n* Migraine headaches that occur more frequently than once per week;\n* Recent, unexplained fainting spells;\n* Problems giving blood samples;\n* Diabetes (unless controlled by diet and exercise alone);\n* Current cancer or treatment for cancer in the past six;\n* Other major medical condition;\n* Current psychiatric disease;\n* Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;\n* Current depression;\n* Bulimia or anorexia;\n* Use (within the past 45 days) of psychiatric medications including antidepressants and anti-psychotics;\n* Use (within the past 30 days) of:\n\n  * Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP), Benzodiazepines, or Barbiturates),\n  * Experimental (investigational) drugs;\n  * Any medications that are known to affect smoking cessation (e.g. clonidine);\n  * Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;\n  * Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid.\n* Use of opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed) within the past 14 days;\n* Smokes more than one cigar a month.\n* Alcohol abuse;\n* Significant adverse reaction to nicotine patches, in the past.\n* Known hypersensitivity to moclobemide or other MAO-A inhibitors.\n* Current participation or recent participation (in the past 30 days) in another smoking study at our center or another research facility.\n* Current participation or recent participation (in the past six months) in another medical research study.","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Jed E Rose, Ph.D.","affiliation":"Duke University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Duke Center for Smoking Cessation","city":"Charlotte","state":"North Carolina","zip":"28210","country":"United States","geoPoint":{"lat":35.22709,"lon":-80.84313}},{"facility":"Duke Center forSmoking Cessation","city":"Durham","state":"North Carolina","zip":"27705","country":"United States","geoPoint":{"lat":35.99403,"lon":-78.89862}},{"facility":"Duke Center for Smoking Cessation","city":"Winston-Salem","state":"North Carolina","zip":"27103","country":"United States","geoPoint":{"lat":36.09986,"lon":-80.24422}}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Of the 76 participants who were enrolled, 38 participants attended Study Session 1: 1 participant voluntarily withdrew prior to Study Session 1, 3 participants were lost to contact prior to Study Session 1, and 34 were withdrawn from the study by the PI or medical staff because they did not meet inclusion criteria or met exclusion criteria.","groups":[{"id":"FG000","title":"Nicotine Patch+Moclobemide","description":"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.\n\nNicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)\n\nPost Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)\n\nMoclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)\n\nPost Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"38"}]},{"type":"Received Moclobemide","achievements":[{"groupId":"FG000","numSubjects":"37"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"16"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"22"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"15"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"7"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Nicotine Patch+Moclobemide","description":"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.\n\nNicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)\n\nPost Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)\n\nMoclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)\n\nPost Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"38"}]}],"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":"38"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46.53","spread":"9.86"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"38"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"38"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Continuous Four-week Abstinence From Smoking","description":"Number of participants who reported continuous four-week abstinence from smoking (weeks 6-10 post target quit date), confirmed by expired air carbon monoxide (CO).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Weeks 6-10 post quit day","groups":[{"id":"OG000","title":"Nicotine Patch+Moclobemide","description":"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.\n\nNicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)\n\nPost Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)\n\nMoclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)\n\nPost Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}]}]},{"type":"SECONDARY","title":"Point Abstinence From Smoking at Six Months Post Quit","description":"Number of participants who reported 7-day point abstinence from smoking at six months post quit, confirmed by expired air CO.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"7 day point abstinence from smoking at six months post quit","groups":[{"id":"OG000","title":"Nicotine Patch+Moclobemide","description":"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.\n\nNicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)\n\nPost Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)\n\nMoclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)\n\nPost Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]}]},{"type":"SECONDARY","title":"Continuous Ten Week Abstinence From Smoking","description":"Number of participants who reported continuous ten-week abstinence from smoking (weeks 1-10 post quit day), confirmed by expired air CO.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"10 weeks post quit day","groups":[{"id":"OG000","title":"Nicotine Patch+Moclobemide","description":"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.\n\nNicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)\n\nPost Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)\n\nMoclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)\n\nPost Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]}]},{"type":"SECONDARY","title":"Percentage of Change in Smoking Withdrawal Symptoms","description":"Withdrawal symptoms will be assessed by questionnaire on Quit Day, 1 week post quit, 3 weeks post quit, 6 weeks post quit,10 weeks post quit and 6 months post quit (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of change","timeFrame":"Quit day and 1 week, 3 weeks, 6 weeks, 10 weeks and 6 months post quit day","groups":[{"id":"OG000","title":"Nicotine Patch+Moclobemide","description":"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.\n\nNicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)\n\nPost Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)\n\nMoclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)\n\nPost Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"}]}],"classes":[{"title":"Craving -- % change 1 week from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-8.07","spread":"7.928"}]}]},{"title":"Craving -- % change 3 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-13.18","spread":"4.144"}]}]},{"title":"Craving -- % change 6 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-14.24","spread":"4.63"}]}]},{"title":"Craving -- % change 10 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-13.41","spread":"6.912"}]}]},{"title":"Craving -- % change 6 months from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"23.71","spread":"63.690"}]}]},{"title":"Negative Affect -- % change 1 week from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-22.82","spread":"4.057"}]}]},{"title":"Negative Affect -- % change 3 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-14.26","spread":"4.327"}]}]},{"title":"Negative Affect -- % change 6 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-21.53","spread":"4.051"}]}]},{"title":"Negative Affect -- % change 10 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-13.92","spread":"4.968"}]}]},{"title":"Negative Affect -- % change 6 months from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"48.87","spread":"65.334"}]}]},{"title":"Appetite -- % change 1 week from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-11.40","spread":"5.486"}]}]},{"title":"Appetite -- % change 3 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-4.39","spread":"7.881"}]}]},{"title":"Appetite -- % change 6 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-17.07","spread":"8.819"}]}]},{"title":"Appetite -- % change 10 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"0.73","spread":"16.033"}]}]},{"title":"Appetite -- % change 6 months from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"27.24","spread":"74.446"}]}]},{"title":"Arousal -- % change 1 week from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"29.81","spread":"8.824"}]}]},{"title":"Arousal -- % change 3 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"29.03","spread":"7.004"}]}]},{"title":"Arousal -- % change 6 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"29.99","spread":"6.915"}]}]},{"title":"Arousal -- % change 10 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"18.95","spread":"6.715"}]}]},{"title":"Arousal -- % change 6 months from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"190.88","spread":"78.496"}]}]},{"title":"Anxiety -- % change 1 week from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-4.65","spread":"3.803"}]}]},{"title":"Anxiety -- % change 3 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-5.80","spread":"4.788"}]}]},{"title":"Anxiety -- % change 6 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-4.48","spread":"5.098"}]}]},{"title":"Anxiety -- % change 10 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-9.44","spread":"6.375"}]}]},{"title":"Anxiety -- % change 6 months from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-38.79","spread":"19.553"}]}]},{"title":"Gastrointestinal -- % change 1 week from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-5.80","spread":"3.365"}]}]},{"title":"Gastrointestinal -- % change 3 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-2.03","spread":"6.602"}]}]},{"title":"Gastrointestinal -- % change 6 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"4.55","spread":"16.189"}]}]},{"title":"Gastrointestinal - % change 10 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-12.20","spread":"5.100"}]}]},{"title":"Gastrointestinal - % change 6 months from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-33.66","spread":"18.204"}]}]},{"title":"Respiratory -- % change 1 week from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"7.26","spread":"6.978"}]}]},{"title":"Respiratory -- % change 3 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"2.06","spread":"11.161"}]}]},{"title":"Respiratory -- % change 6 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-5.16","spread":"8.628"}]}]},{"title":"Respiratory -- % change 10 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-13.28","spread":"8.696"}]}]},{"title":"Respiratory -- % change 6 months from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-38.79","spread":"19.553"}]}]},{"title":"Habit -- % change 1 week from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-9.26","spread":"7.272"}]}]},{"title":"Habit -- % change 3 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-11.41","spread":"6.309"}]}]},{"title":"Habit -- % change 6 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-12.22","spread":"7.705"}]}]},{"title":"Habit -- % change 10 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"1.49","spread":"14.642"}]}]},{"title":"Habit -- % change 6 months from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-38.79","spread":"19.553"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Safety of Moclobemide + Nicotine Patch","description":"Safety of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants rating side effects \\> \"moderate\".","populationDescription":"Participants who received Moclobemide.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch","groups":[{"id":"OG000","title":"Nicotine Patch+Moclobemide","description":"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.\n\nNicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)\n\nPost Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)\n\nMoclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)\n\nPost Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"37"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21"}]}]}]},{"type":"SECONDARY","title":"Percentage of Change in Expired Air Carbon Monoxide (CO) During the First Week of Nicotine Patch Treatment.","description":"The initial response to nicotine patch will be assessed by looking at the percent change in expired air carbon monoxide (CO) at the end of week one (Study Visit 2) relative to baseline (Study Visit 1).","populationDescription":"Participants who received Moclobemide.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of change","timeFrame":"Baseline and 1 week","groups":[{"id":"OG000","title":"Nicotine Patch+Moclobemide","description":"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.\n\nNicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)\n\nPost Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)\n\nMoclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)\n\nPost Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"37"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-18.38","spread":"5.551"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Tolerability of Moclobemide + Nicotine Patch","description":"Tolerability of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants requiring dose reductions (or discontinuation of medication).","populationDescription":"Participants who received Moclobemide.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch","groups":[{"id":"OG000","title":"Nicotine Patch+Moclobemide","description":"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.\n\nNicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)\n\nPost Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)\n\nMoclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)\n\nPost Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"37"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"17"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.","description":"One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.","eventGroups":[{"id":"EG000","title":"Nicotine Patch+Moclobemide","description":"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.\n\nNicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)\n\nPost Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)\n\nMoclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)\n\nPost Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)","seriousNumAffected":0,"seriousNumAtRisk":37,"otherNumAffected":29,"otherNumAtRisk":37}],"otherEvents":[{"term":"Insomnia","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":21,"numAffected":12,"numAtRisk":37}]},{"term":"Tiredness","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":14,"numAffected":12,"numAtRisk":37}]},{"term":"Nightmares","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":37}]},{"term":"Vivid dreams","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":27,"numAffected":13,"numAtRisk":37}]},{"term":"Dizziness","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":37}]},{"term":"Headache","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":7,"numAtRisk":37}]},{"term":"Excessive sweating","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":14,"numAffected":4,"numAtRisk":37}]},{"term":"Increased appetite","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":7,"numAtRisk":37}]},{"term":"Loss of appetite","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":37}]},{"term":"Altered taste","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":6,"numAtRisk":37}]},{"term":"Dry mouth","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":18,"numAffected":9,"numAtRisk":37}]},{"term":"Thirst","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":19,"numAffected":10,"numAtRisk":37}]},{"term":"Cough","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":4,"numAtRisk":37}]},{"term":"Chest Pain","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":37}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":37}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":37}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":37}]},{"term":"Heartburn","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":37}]},{"term":"Muscle / joint pain","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":5,"numAtRisk":37}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":5,"numAtRisk":37}]},{"term":"Depression","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":2,"numAtRisk":37}]},{"term":"Agitation / restlessness","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":4,"numAtRisk":37}]},{"term":"Itching at patch site","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":14,"numAffected":11,"numAtRisk":37}]},{"term":"Rash at patch site","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":37}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Dr. Jed E. Rose","organization":"Duke Center for Smoking Cessation","email":"jed.rose@duke.edu","phone":"919-668-5055"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D014029","term":"Tobacco Use Disorder"},{"id":"D016540","term":"Smoking Cessation"}],"ancestors":[{"id":"D019966","term":"Substance-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D015438","term":"Health Behavior"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D061485","term":"Tobacco Use Cessation Devices"},{"id":"D009538","term":"Nicotine"},{"id":"D020912","term":"Moclobemide"}],"ancestors":[{"id":"D013812","term":"Therapeutics"},{"id":"D012991","term":"Solanaceous Alkaloids"},{"id":"D000470","term":"Alkaloids"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D011725","term":"Pyridines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D001549","term":"Benzamides"},{"id":"D000577","term":"Amides"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D001565","term":"Benzoates"},{"id":"D000146","term":"Acids, Carbocyclic"},{"id":"D002264","term":"Carboxylic Acids"},{"id":"D002723","term":"Chlorobenzoates"},{"id":"D001555","term":"Benzene Derivatives"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"}]}},"hasResults":true}