Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-26 @ 11:30 AM
Study NCT ID:
NCT01023659
Status:
COMPLETED
Last Update Posted:
2018-01-24
First Post:
2009-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Distribution of Bupropion and Varenicline to Increase Smoking Cessation Attempts
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016642', 'term': 'Bupropion'}, {'id': 'D000068580', 'term': 'Varenicline'}], 'ancestors': [{'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011810', 'term': 'Quinoxalines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'peter.selby@camh.ca', 'phone': '416-535-8501', 'title': 'Dr. Peter Selby', 'phoneExt': '74946', 'organization': 'Centre for Addiction and Mental Heatlh'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Serious and other \\[non-serious\\] adverse events were not collected or assessed as part of the study', 'eventGroups': [{'id': 'EG000', 'title': 'Bupropion + Motivational Emails', 'description': 'participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.\n\nbupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks\n\nmotivational emails : brief motivational emails, sent weekly for 12 weeks', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Motivational Emails', 'description': 'participants receive weekly motivational emails for 12 weeks.\n\nmotivational emails : brief motivational emails, sent weekly for 12 weeks', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Varenicline + Motivational Emails', 'description': 'participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.\n\nmotivational emails : brief motivational emails, sent weekly for 12 weeks\n\nvarenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '7-day Point Prevalence of Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupropion + Motivational Emails', 'description': 'participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.\n\nbupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks\n\nmotivational emails : brief motivational emails, sent weekly for 12 weeks'}, {'id': 'OG001', 'title': 'Motivational Emails', 'description': 'participants receive weekly motivational emails for 12 weeks.\n\nmotivational emails : brief motivational emails, sent weekly for 12 weeks'}, {'id': 'OG002', 'title': 'Varenicline + Motivational Emails', 'description': 'participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.\n\nmotivational emails : brief motivational emails, sent weekly for 12 weeks\n\nvarenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6-month', 'description': '7-day point prevalence of abstinence was assessed by the question "Have you had a cigarette, even a puff, in the past 7 days?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of eligible participants who either received bupropion + motivational emails, varenicline + motivational emails or motivational emails alone (because they either did not attend a physician visit or their physician decided not to prescribe them bupropion or varenicline)'}, {'type': 'PRIMARY', 'title': 'Proportion of Eligible Participants Who Were Able to Attend an Appointment With a Physician', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Eligible Participants', 'description': 'All participants who were eligible to receive medication'}], 'classes': [{'categories': [{'measurements': [{'value': '588', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of Treatment', 'description': 'Proportion of eligible participants who were able to attend an appointment with a physician to have the prescription signed', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'total number of eligible participants in study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bupropion + Motivational Emails', 'description': 'participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.\n\nbupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks\n\nmotivational emails : brief motivational emails, sent weekly for 12 weeks'}, {'id': 'FG001', 'title': 'Motivational Emails', 'description': 'participants receive weekly motivational emails for 12 weeks.\n\nmotivational emails : brief motivational emails, sent weekly for 12 weeks'}, {'id': 'FG002', 'title': 'Varenicline + Motivational Emails', 'description': 'participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.\n\nmotivational emails : brief motivational emails, sent weekly for 12 weeks\n\nvarenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '258'}, {'groupId': 'FG001', 'numSubjects': '365'}, {'groupId': 'FG002', 'numSubjects': '264'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '185'}, {'groupId': 'FG001', 'numSubjects': '137'}, {'groupId': 'FG002', 'numSubjects': '165'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '228'}, {'groupId': 'FG002', 'numSubjects': '99'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '228'}, {'groupId': 'FG002', 'numSubjects': '99'}]}]}], 'recruitmentDetails': 'Participants visited the study website, provided consent and completed an on-line assessment. Eligible participants received a personalized script to take to their physician, who could prescribe varenicline or bupropion for 12 weeks, or neither.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}, {'value': '887', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Bupropion + Motivational Emails', 'description': 'participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.\n\nbupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks\n\nmotivational emails : brief motivational emails, sent weekly for 12 weeks'}, {'id': 'BG001', 'title': 'Motivational Emails', 'description': 'participants receive weekly motivational emails for 12 weeks.\n\nmotivational emails : brief motivational emails, sent weekly for 12 weeks'}, {'id': 'BG002', 'title': 'Varenicline + Motivational Emails', 'description': 'participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.\n\nmotivational emails : brief motivational emails, sent weekly for 12 weeks\n\nvarenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '44.0', 'spread': '12.8', 'groupId': 'BG002'}, {'value': '41.9', 'spread': '12.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}, {'value': '503', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '384', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '258', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}, {'value': '887', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education level- less than high school diploma', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with less than high school diploma', 'unitOfMeasure': 'Participants'}, {'title': 'Annual household income:$20,000 or less', 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '373', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'number participants with annual income equal or less than $20,000', 'unitOfMeasure': 'Participants'}, {'title': '# Participants currently employed', 'classes': [{'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '472', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants who report being employed', 'unitOfMeasure': 'Participants'}, {'title': '# cigarettes smoked per day', 'classes': [{'title': '10-19 cpd', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}]}]}, {'title': '20-29 cpd', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '457', 'groupId': 'BG003'}]}]}, {'title': '30 + cpd', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': '\\# participants in cpd smoking category', 'unitOfMeasure': 'participants'}, {'title': '# participants who smoke first morning cigarette within 5 minutes', 'classes': [{'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '426', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '\\# participants who report smoking first morning cigarette within 5 minutes after waking-up.', 'unitOfMeasure': 'Participants'}, {'title': 'Years since started smoking daily', 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '24.2', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '30.0', 'spread': '12.7', 'groupId': 'BG002'}, {'value': '27.5', 'spread': '12.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Mean (SD) years since started smoking daily', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '# participants with less than 3 quit attempts', 'classes': [{'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '478', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Confidence in Quitting', 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '7.5', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '7.8', 'spread': '2.0', 'groupId': 'BG002'}, {'value': '7.7', 'spread': '2.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': '10 point scale from: 1- Very little confidence quitting ...to.. 10-Very confident in quitting', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '# Participants who report previous use of smoking cessation medication', 'classes': [{'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '470', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '\\# participants who report previous use of medication for smoking cessation', 'unitOfMeasure': 'Participants'}, {'title': '# participants with longest period of abstinence from smoking- less than 1 week', 'classes': [{'categories': [{'title': 'less than 1 week', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '264', 'groupId': 'BG003'}]}, {'title': '1 week or more', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}, {'value': '623', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '\\# participants who report longest period of abstinence from smoking of less than 1 week', 'unitOfMeasure': 'Participants'}, {'title': 'Participants who report all or most of my friends smoke', 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '344', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'self report: Proportion of friends that smoke - all or most of my friends smoke', 'unitOfMeasure': 'Participants'}, {'title': 'Lives with other smoker(s)', 'classes': [{'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '498', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Yes- lives with other smokers', 'unitOfMeasure': 'Participants'}, {'title': 'History of drug or alcohol problem', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self report history of alcohol or drug problem', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 893}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2009-11-30', 'resultsFirstSubmitDate': '2013-02-14', 'studyFirstSubmitQcDate': '2009-12-01', 'lastUpdatePostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-02-14', 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '7-day Point Prevalence of Abstinence', 'timeFrame': '6-month', 'description': '7-day point prevalence of abstinence was assessed by the question "Have you had a cigarette, even a puff, in the past 7 days?"'}, {'measure': 'Proportion of Eligible Participants Who Were Able to Attend an Appointment With a Physician', 'timeFrame': 'End of Treatment', 'description': 'Proportion of eligible participants who were able to attend an appointment with a physician to have the prescription signed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking cessation', 'Bupropion', 'Varenicline', 'Population-level', 'Mass distribution', 'Drug Therapy'], 'conditions': ['Tobacco Use Disorder', 'Smoking', 'Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '26429100', 'type': 'RESULT', 'citation': 'Selby P, Hussain S, Voci S, Zawertailo L. Empowering smokers with a web-assisted tobacco intervention to use prescription smoking cessation medications: a feasibility trial. Implement Sci. 2015 Oct 1;10:139. doi: 10.1186/s13012-015-0329-7.'}]}, 'descriptionModule': {'briefSummary': 'Bupropion and varenicline are indicated for smoking cessation. The objectives of this study are two-fold: (1) to explore the logistic feasibility of distributing bupropion and varenicline free of charge to treatment-seeking smokers in the province of Ontario, Canada and (2) to evaluate the real-world effectiveness of bupropion and varenicline treatment in Ontario compared to a no-drug comparison group. In an open label study, Ontario smokers who smoke 10 or more cigarettes per day and intend to quit smoking in the next 30 days, will enroll via the study website, visit their physician to receive a prescription for bupropion or varenicline for 12 weeks or neither if they so choose, forming the no-drug comparison group. All participants will receive weekly motivational emails for 12 weeks. Abstinence measures will be taken at 4, 8 and 12 weeks and at 6 and 12 months. The proportion of eligible participants who were able to confirm an appointment with a physician to receive the prescription will be also measured.', 'detailedDescription': "Bupropion and varenicline are effective pharmacotherapies for smoking cessation, but their population level impact is limited by a combination of factors. Both bupropion and varenicline are only available through prescription, however smoking cessation clinics are few in number and only about 25% of smokers receive information on smoking cessation aids from their healthcare provider. Mass distribution approaches, bypassing clinics and physicians, have been successful for nicotine replacement therapy in many jurisdictions, including Ontario. However, bupropion and varenicline have the potential to make a greater impact given their superior results from the clinical trials. Bupropion and varenicline present a unique challenge as they are prescribed medications, therefore we have proposed a variant of the mass distribution method to test whether it is practical to distribute them to a large number of people over a expansive geographic area (i.e., Ontario).\n\nWe hypothesize that engaging smokers with the opportunity to receive free bupropion or varenicline, to initiate an appointment with their physician to obtain a prescription that would be filled and mailed to the smoker from a central pharmacy would be a logistically feasible approach to reach high number of smokers from a wide geographic area. Our second hypothesis is that consistent with the results from clinical studies, in the general population varenicline would be associated with a higher abstinence rate than bupropion, and both varenicline and bupropion groups would achieve higher abstinence rates than those making quit attempts without any pharmacotherapy aid.\n\nThis is an open label, proof-of-concept study, wherein 2000 eligible participants will have the opportunity to receive bupropion (Zyban®) or varenicline (Champix®) for 12 weeks in conjunction with weekly motivational emails. Eligible participants will discuss with their doctor which of the two medications is appropriate for them to use as smoking cessation aid. It is also possible that the participant and his/her doctor may decide not to pursue smoking cessation using either of these medications. These participants will form a third intervention group, receiving only the weekly motivational emails. All participants will set a quit date of their choosing, but those receiving medication will set a quit date 7 days after starting the medication. The participants will enroll in the study via the study's website, at which time they will read the consent form, answer the eligibility questions and complete the baseline questionnaire. Data related to the outcome measures and adverse events will be collected at 4, 8 and 12 weeks after the start of treatment and at 6 and 12 months after the end of treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female, at least 18 years of age, resident of Ontario, smoke at least 10 cigarettes per day, had smoked daily for at least the past 3 months, had smoked at least 100 cigarettes in their lifetime and intended to quit smoking in the next 30 days.\n\nExclusion Criteria:\n\n* history of brain injury or seizure(s); pregnancy, lactation or risk of becoming pregnant; allergy or sensitivity to bupropion or varenicline; current use of monoamine oxidase inhibitors (MAOIs), thioridazine, varenicline or buproprion; severe liver impairment; or history of anorexia and /or bulimina.'}, 'identificationModule': {'nctId': 'NCT01023659', 'briefTitle': 'Distribution of Bupropion and Varenicline to Increase Smoking Cessation Attempts', 'organization': {'class': 'OTHER', 'fullName': 'Centre for Addiction and Mental Health'}, 'officialTitle': 'An Innovative Approach to Maximizing the Impact of Efficacious Pharmacotherapies on Smoking Cessation Attempts.', 'orgStudyIdInfo': {'id': '068/2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bupropion + motivational emails', 'description': 'participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.', 'interventionNames': ['Drug: bupropion', 'Behavioral: motivational emails']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Varenicline + motivational emails', 'description': 'participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.', 'interventionNames': ['Drug: varenicline', 'Behavioral: motivational emails']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Motivational emails', 'description': 'participants receive weekly motivational emails for 12 weeks.', 'interventionNames': ['Behavioral: motivational emails']}], 'interventions': [{'name': 'bupropion', 'type': 'DRUG', 'otherNames': ['Zyban'], 'description': 'bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks', 'armGroupLabels': ['Bupropion + motivational emails']}, {'name': 'varenicline', 'type': 'DRUG', 'otherNames': ['Champix'], 'description': 'varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks', 'armGroupLabels': ['Varenicline + motivational emails']}, {'name': 'motivational emails', 'type': 'BEHAVIORAL', 'description': 'brief motivational emails, sent weekly for 12 weeks', 'armGroupLabels': ['Bupropion + motivational emails', 'Motivational emails', 'Varenicline + motivational emails']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 1P7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Addiction and Mental Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Peter Selby, MD, MHSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Addiction and Mental Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre for Addiction and Mental Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ontario Ministry of Health and Long Term Care', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Director, Addictions Program', 'investigatorFullName': 'Dr. Peter Selby', 'investigatorAffiliation': 'Centre for Addiction and Mental Health'}}}}