Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-02 @ 1:07 AM
Study NCT ID:
NCT01010204
Status:
COMPLETED
Last Update Posted:
2017-12-04
First Post:
2009-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder
Sponsor:
Organization:
Raw JSON
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Roy Chengappa, Md', 'organization': 'Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Varenicline', 'description': 'We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.\n\nVarenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. 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Patients will be instructed to take study medication after meals with a glass of water.', 'otherNumAtRisk': 29, 'otherNumAffected': 25, 'seriousNumAtRisk': 29, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'flatulance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'heart burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'gastroesophageal reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'mood swings', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'bad taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'arthralgia/pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue/lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'asthenia-weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'runny nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'exacerbation of anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'agitation, hostility, alcohol drug abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'asthma with acute exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'alcohol intoxication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'upper left arm weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'chest pain, left hand numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': 'We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.\n\nVarenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. 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After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence at 12 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'bipolar subjects'}, {'type': 'PRIMARY', 'title': '7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': 'We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.\n\nVarenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.\n\nPlacebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'bipolar patients'}, {'type': 'SECONDARY', 'title': 'Participants Experiencing Neuropsychiatric Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': 'We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.\n\nVarenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.\n\nPlacebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks', 'description': 'Evaluate the safety of varenicline in treatment-emergent hypomania, mania, mixed or depressed episodes or being associated suicidal or aggressive behavior or psychotic symptoms when used as adjunctive treatment in participants with bipolar disorder.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Bipolar Patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Varenicline', 'description': 'We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.\n\nVarenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.\n\nPlacebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'psychiatric hospitalization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Varenicline', 'description': 'We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.\n\nVarenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.\n\nPlacebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.7', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '46.2', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '45.95', 'spread': '9.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-27', 'studyFirstSubmitDate': '2009-11-05', 'resultsFirstSubmitDate': '2015-02-27', 'studyFirstSubmitQcDate': '2009-11-06', 'lastUpdatePostDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-02-27', 'studyFirstPostDateStruct': {'date': '2009-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks', 'timeFrame': '12 weeks', 'description': 'To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence at 12 weeks'}, {'measure': '7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks', 'timeFrame': '24 weeks', 'description': 'To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence'}], 'secondaryOutcomes': [{'measure': 'Participants Experiencing Neuropsychiatric Events', 'timeFrame': '24 weeks', 'description': 'Evaluate the safety of varenicline in treatment-emergent hypomania, mania, mixed or depressed episodes or being associated suicidal or aggressive behavior or psychotic symptoms when used as adjunctive treatment in participants with bipolar disorder.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Varenicline', 'Chantix', 'Smoking', 'Bipolar Disorder'], 'conditions': ['Smoking Cessation', 'Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '25006684', 'type': 'RESULT', 'citation': 'Chengappa KN, Perkins KA, Brar JS, Schlicht PJ, Turkin SR, Hetrick ML, Levine MD, George TP. Varenicline for smoking cessation in bipolar disorder: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014 Jul;75(7):765-72. doi: 10.4088/JCP.13m08756.'}, {'pmid': '37142273', 'type': 'DERIVED', 'citation': 'Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.'}, {'pmid': '34611902', 'type': 'DERIVED', 'citation': 'Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.'}]}, 'descriptionModule': {'briefSummary': "The investigators' hypothesis is that add-on varenicline will be effective (versus placebo) in initiating abstinence from smoking in subjects with stable, euthymic bipolar disorder who are motivated to quit smoking within four weeks. This primary outcome will be assessed from randomization to 12 weeks or end of the treatment phase of the study. Secondarily, the investigators also hypothesize that varenicline will prevent relapse in the subsequent 12-weeks follow-up non-treatment phase. Furthermore, the investigators plan to test the effectiveness of varenicline in reducing nicotine withdrawal symptoms or urges to smoke, as well as its safety for use in stable bipolar patients when used as an add-on treatment for smoking cessation.\n\nThe investigators plan to test these hypotheses by conducting a randomized, placebo-controlled add-on treatment trial of Chantix with 60 recruited subjects diagnosed with DSM-IV bipolar disorder for a period of three months. The investigators will follow-up with them three months later to evaluate extended abstinence.", 'detailedDescription': 'OBJECTIVE:\n\nOur primary objective is to determine if adjunctive varenicline will be efficacious (vs. placebo) in initiating abstinence from smoking cigarettes in subjects with stable bipolar disorder who are motivated to quit smoking during a 12-week treatment phase. A secondary outcome is to determine whether those who initiated abstinence during the 12-week treatment phase will maintain abstinence in the subsequent three-month follow-up period off study medications.\n\nAdditional outcomes: we plan to test the effectiveness of varenicline in reducing nicotine withdrawal symptoms or urges to smoke, as well as its safety for use in stable bipolar patients when used as an adjunctive treatment for smoking cessation.\n\nRESEARCH PLAN:\n\nWe plan to test these hypotheses by conducting a randomized, placebo-controlled, treatment trial of Chantix. Measures of CO levels in expired air (10 ppm or lower), self-reported abstinence, and psychopathology ratings will be used to evaluate primary and secondary outcomes along with safety assessments. Smoking abstinence is defined as 7-day point prevalence of self-reported no smoking verified objectively by expired CO levels of 10 ppm or less, and will be assessed at 12-weeks (or end of treatment phase) as the primary outcome. The same criterion will be used to assess maintenance of abstinence in the non-treatment phase, i.e. at 24 weeks or end of study.\n\nMETHODS:\n\nSeventy-six subjects with DSM-IV bipolar disorder will be recruited from Western Psychiatric Institute and Clinic and Dubois Regional Medical Center. Using a 1:1 Randomization, which also takes into account gender, subjects who sign an informed consent document will be randomized to receive Chantix or placebo.\n\nIt is expected that 16 of the 76 may not meet inclusion/exclusion criteria, leaving 60 consenting adults aged 18-65 years with DSM-IV bipolar disorder, which will be confirmed by the MINI (Sheehan et al.) Subjects must meet smoking inclusion criteria of smoking 10 or more cigarettes per day. Motivation to quit smoking (score of at least 7 on the Contemplation Ladder Scale) as well as stable mood status (Young Mania Rating Scale score of eight or less, Montgomery Asberg Depression Rating Scale Score of eight or less, with low scores on suicide aggression and psychotic items over a four-week period required. Subjects who have received pharmacological agents for smoking cessation such as bupropion, nicotine replacement treatment, or who have participated in behavioral treatment for smoking cessation more than three months before beginning the study will be permitted to enroll in the study. Anyone experiencing serious side-effects from varenicline in the past or who has already participated in a smoking cessation study with varenicline will be excluded.\n\nChantix or placebo will be administered using random assignment at a dose of 0.5 mg by mouth for three days, followed by 0.5 mg twice per day for four days. After the first week, the dose will be increased to 1 mg twice daily for 11 weeks. Subjects must be able to tolerate a minimum of 1 mg per day to continue in the study.\n\nSubjects will pick a target date between visit 3 (to permit titration to the target dose of 2 mg per day) and visit 4 to quit smoking. There needs to be at least 24 hours (preferably 48) between the time of the last cigarette usage and visit 4, where a CO measurement will be taken.\n\nThose who are unable to quit at this time will be given an opportunity to pick additional quit dates. All visits will be scheduled a week apart and subjects will continue to take their double-blind medication and receive counseling sessions for smoking cessation. Study medication will be stopped after 12 weeks, and there will be weekly visits to evaluate abstinence.\n\nSome standard psychopathology rating scales and smoking rating scales will be administered to evaluate secondary aims such as the degree of nicotine withdrawal symptoms and the impact of residual symptoms on bipolar disorder. Safety will be assessed through the administration of specific mania and depression rating scales including and the Columbia -Suicide Severity Rating Scale, as well as a comprehensive health assessment. This includes a medical history and evaluation of laboratory measures. Any adverse effects of medication will be assessed by asking questions at each visit and if necessary, contacting the subject by phone outside the scheduled visits.\n\nSIGNIFICANCE The rate of cigarette smoking among people with psychiatric disorders remains exceedingly high; nearly two to four times as high as those in the general population. Patients with bipolar disorder may have the highest rates of smoking as compared with people with other psychiatric diagnoses. To date, there have been no treatment trials of adequate size to measure smoking cessation rates in people with bipolar disorder. If varenicline proves to be an effective in helping people with bipolar disorder to stop smoking, or even to reduce their smoking rates, this could play an important role in improving their health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Subject inclusion criteria\n\n1. DSM IV-TR Bipolar I or II or Bipolar NOS Disorder\n2. Ability to provide written informed consent\n3. Male or Female patients, all races, ages 18 to 65 years inclusive\n4. Negative serum pregnancy test for females of child-bearing potential. Patients must agree to one of the following birth control methods: an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g., Norplant), or an injectable contraceptive (e.g., Depo Provera) for at least 1 month prior to entering the study and will continue its use through at least 30 days after the last dose of study medication or a barrier method of contraception, e.g., condom and/or diaphragm with spermicide while participating in the study through at least 30 days after the last dose of study medication or abstinence.\n5. MADRS total scores ≤ 8 (past 4 weeks) (suicidal item, score ≤ 1, past 4 weeks).\n6. Y-MRS scores ≤ 8 (past 4 weeks) irritability, speech content, disruptive, or aggressive behavior items score ≤ 3, past 4 weeks)\n7. Stable doses of primary bipolar maintenance medication for at least 8 weeks prior to randomization\n8. No psychiatric hospitalization or Emergency Room Visits for psychiatric issues in the 6-month period prior to randomization\n9. No suicidal attempts or behavior history past 6 months\n10. No aggressive or violent acts or behavior by history past 6 months\n\nSubject exclusion criteria\n\n1. Uncontrolled seizure disorders and other neurological disorders including Huntington's Chorea, Multiple Sclerosis, Cerebral Palsy, and stroke (cerebrovascular accident, CVA).\n2. Current alcohol or other substance abuse or dependence within the last 3 months (caffeine will be permitted, nicotine dependence is part of inclusion criteria), including a case-by-case evaluation of those who meet remission criteria and who are on long-term substance abuse and/or alcohol abuse treatment.\n3. Female patients who are pregnant, lactating or likely to become pregnant in next 6 months\n4. Uncontrolled diabetes mellitus, asthma, seizure disorder, uncontrolled hypertension, (uncontrolled hypertension is defined as Systolic BP \\> 150 mm or Hg or diastolic BP \\> 95 mm or Hg on 2 consecutive BP readings 15 minutes apart at the time of screening) or unstable medical illness. Moderate to severe renal disease - moderate renal failure is defined as serum Creatinine \\>1.3 mg/dl in women and \\> 1.5 mg/dl in men, at the time of screening.\n5. Severe dizziness or fainting due to orthostatic blood pressure changes\n6. Known hypersensitivity to varenicline\n7. Current use of cimetidine\n8. Current treatment with heparin, warfarin, or lidocaine\n9. Comorbid psychiatric condition diagnosed within the last three months.\n\nSubject smoking inclusion criteria\n\n1. Score of 7 or greater on the Contemplation Ladder, and willing to pick a target quit date within the next 4 weeks.\n2. Smoke \\> 10 cigarettes per day.\n3. Expired breath CO level \\> 10 ppm at screening and randomization.\n4. No use of smoking cessation medication and/or behavioral treatment for smoking cessation in the past three months.\n5. No current use of any nicotine replacement treatment.\n6. Not using any tobacco products other than cigarettes.\n7. No current treatment for smoking cessation (hypnosis, acupuncture, others).\n8. No current use or past treatment failure with varenicline.\n9. No current treatment with bupropion for smoking cessation."}, 'identificationModule': {'nctId': 'NCT01010204', 'acronym': 'BEST', 'briefTitle': 'Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder', 'orgStudyIdInfo': {'id': 'R21MH087928', 'link': 'https://reporter.nih.gov/quickSearch/R21MH087928', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R21MH087928', 'link': 'https://reporter.nih.gov/quickSearch/R21MH087928', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Varenicline', 'description': 'We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.', 'interventionNames': ['Drug: Varenicline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Varenicline', 'type': 'DRUG', 'otherNames': ['Chantix'], 'description': 'Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.', 'armGroupLabels': ['Varenicline']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Comparator'], 'description': 'Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15801', 'city': 'DuBois', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Dubois Regional Medical Center', 'geoPoint': {'lat': 41.11923, 'lon': -78.76003}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Western Psychiatric Institute and Clinic', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'K.N. Roy Chengappa', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh School of Medicine Department of Psychiatry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'K.N. Roy Chengappa', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'K.N. Roy Chengappa', 'investigatorAffiliation': 'University of Pittsburgh'}}}}