Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-28 @ 7:21 AM
Study NCT ID:
NCT00937235
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2009-07-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Smoking Among Individuals With PTSD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068580', 'term': 'Varenicline'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'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'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'foa@mail.med.upenn.edu', 'phone': '2157463327', 'title': 'Dr. Edna Foa', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '1. PPA verified by CO/cotinine was only assessed at two time-points (post-treatment, and follow-up)\n2. medication adherence for varenicline was measured using pill count by the study nurse'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected over the entire duration of data collection (2009-2015).', 'description': 'Participants were assessed at each visit for adverse events (which typically occurred weekly).', 'eventGroups': [{'id': 'EG000', 'title': 'Integrated Treatment', 'description': 'Prolonged Exposure + Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation\n\nProlonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 64, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Varenicline', 'description': 'Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 58, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Miscellaneous', 'notes': 'Increased fatigue, increased/decreased appetite, dry mouth, diarrhea, etc', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 58}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization secondary to drug or alcohol relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory issue', 'notes': 'Hospitalizations secondary to respiratory conditions (pneumonia, COPD, flu) for reasons unrelated to study procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cocaine relapse with no hospitalization', 'notes': 'Cocaine relapse with no hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken ankle + hospitalization', 'notes': 'Broken ankle unrelated to study procedures that required hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization (unrelated)', 'notes': 'Reason for hospitalization unknown, but noted as unrelated to study procedures (general medical issue)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With 7-day Point Prevalence Smoking Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Treatment', 'description': 'Prolonged Exposure + Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation\n\nProlonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders'}, {'id': 'OG001', 'title': 'Varenicline', 'description': 'Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 3-month follow-up (6-month post-quit day)', 'description': 'Number of participants reporting seven-day point prevalence abstinence (PPA), which was defined as self-reported abstinence for 7 days prior to the assessment, serum cotinine level of \\<15ng/ml, and CO \\< 10 ppm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Serum Cotinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Treatment', 'description': 'Prolonged Exposure + Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation\n\nProlonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders'}, {'id': 'OG001', 'title': 'Varenicline', 'description': 'Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation'}], 'classes': [{'categories': [{'measurements': [{'value': '156.0', 'spread': '119.4', 'groupId': 'OG000'}, {'value': '149.2', 'spread': '149.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At end of 3-month follow-up', 'description': 'Level of cotinine in blood', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Treatment', 'description': 'Prolonged Exposure + Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation\n\nProlonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders'}, {'id': 'OG001', 'title': 'Varenicline', 'description': 'Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation'}], 'classes': [{'categories': [{'measurements': [{'value': '11.19', 'spread': '10.63', 'groupId': 'OG000'}, {'value': '18.84', 'spread': '11.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-treatment, occurring 12 weeks after the start of treatment (week 0)', 'description': 'Posttraumatic Symptom Scale Interview at post-treatment assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51.\n\nHigher scores indicate higher/worse levels of PTSD.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Treatment', 'description': 'Prolonged Exposure + Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation\n\nProlonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders'}, {'id': 'OG001', 'title': 'Varenicline', 'description': 'Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation'}], 'classes': [{'categories': [{'measurements': [{'value': '10.35', 'spread': '11.73', 'groupId': 'OG000'}, {'value': '16.74', 'spread': '12.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-month follow-up', 'description': 'Posttraumatic Symptom Scale Interview at 3-month follow-up assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51.\n\nHigher scores indicate higher/worse levels of PTSD.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Treatment', 'description': 'Prolonged Exposure + Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation\n\nProlonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders'}, {'id': 'OG001', 'title': 'Varenicline', 'description': 'Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation'}], 'classes': [{'categories': [{'measurements': [{'value': '6.34', 'spread': '6.00', 'groupId': 'OG000'}, {'value': '11.84', 'spread': '7.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0)', 'description': 'Hamilton Depression scale (HAM-D) at post-treatment assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50.\n\nHigher scores indicate higher/worse levels of depression.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Treatment', 'description': 'Prolonged Exposure + Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation\n\nProlonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders'}, {'id': 'OG001', 'title': 'Varenicline', 'description': 'Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation'}], 'classes': [{'categories': [{'measurements': [{'value': '6.95', 'spread': '7.39', 'groupId': 'OG000'}, {'value': '11.45', 'spread': '7.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-month follow-up', 'description': 'Hamilton Depression scale (HAM-D) at 3-month followup assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50.\n\nHigher scores indicate higher/worse levels of depression.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Treatment', 'description': 'Prolonged Exposure + Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation\n\nProlonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders'}, {'id': 'OG001', 'title': 'Varenicline', 'description': 'Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation'}], 'classes': [{'categories': [{'measurements': [{'value': '14.31', 'spread': '29.00', 'groupId': 'OG000'}, {'value': '17.03', 'spread': '28.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit', 'description': 'Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit', 'unitOfMeasure': 'Number of Cigarettes Smoked', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'TLFB - Cigarettes Smoked Week Before 3-Month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Integrated Treatment', 'description': 'Prolonged Exposure + Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation\n\nProlonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders'}, {'id': 'OG001', 'title': 'Varenicline', 'description': 'Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation'}], 'classes': [{'categories': [{'measurements': [{'value': '32.92', 'spread': '45.64', 'groupId': 'OG000'}, {'value': '25.85', 'spread': '44.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-month follow-up', 'description': 'Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit', 'unitOfMeasure': 'Number of Cigarettes Smoked', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Integrated Treatment', 'description': 'Prolonged Exposure + Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation\n\nProlonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders'}, {'id': 'FG001', 'title': 'Varenicline', 'description': 'Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Participants were recruited through advertisements and referrals to the University of Pennsylvania's Center for the Treatment and Study of Anxiety (CTSA), Transdisciplinary Tobacco Use Research Center (TTURC), and the Philadelphia VA Hospital."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Integrated Treatment', 'description': 'Prolonged Exposure + Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation\n\nProlonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders'}, {'id': 'BG001', 'title': 'Varenicline', 'description': 'Varenicline + Medication Management Counseling\n\nVarenicline: 1 mg tablets, orally, twice daily x 12 weeks\n\nMedication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.8', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '42.6', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '42.7', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-11', 'studyFirstSubmitDate': '2009-07-08', 'resultsFirstSubmitDate': '2017-03-28', 'studyFirstSubmitQcDate': '2009-07-08', 'lastUpdatePostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-07', 'studyFirstPostDateStruct': {'date': '2009-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With 7-day Point Prevalence Smoking Abstinence', 'timeFrame': 'At 3-month follow-up (6-month post-quit day)', 'description': 'Number of participants reporting seven-day point prevalence abstinence (PPA), which was defined as self-reported abstinence for 7 days prior to the assessment, serum cotinine level of \\<15ng/ml, and CO \\< 10 ppm.'}], 'secondaryOutcomes': [{'measure': 'Blood Serum Cotinine', 'timeFrame': 'At end of 3-month follow-up', 'description': 'Level of cotinine in blood'}, {'measure': 'Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment', 'timeFrame': 'Post-treatment, occurring 12 weeks after the start of treatment (week 0)', 'description': 'Posttraumatic Symptom Scale Interview at post-treatment assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51.\n\nHigher scores indicate higher/worse levels of PTSD.'}, {'measure': 'Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up', 'timeFrame': '3-month follow-up', 'description': 'Posttraumatic Symptom Scale Interview at 3-month follow-up assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51.\n\nHigher scores indicate higher/worse levels of PTSD.'}, {'measure': 'Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment', 'timeFrame': 'Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0)', 'description': 'Hamilton Depression scale (HAM-D) at post-treatment assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50.\n\nHigher scores indicate higher/worse levels of depression.'}, {'measure': 'Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up', 'timeFrame': '3-month follow-up', 'description': 'Hamilton Depression scale (HAM-D) at 3-month followup assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50.\n\nHigher scores indicate higher/worse levels of depression.'}, {'measure': 'TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)', 'timeFrame': 'Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit', 'description': 'Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit'}, {'measure': 'TLFB - Cigarettes Smoked Week Before 3-Month Follow-up', 'timeFrame': '3-month follow-up', 'description': 'Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Smoking Cessation', 'Anxiety', 'Behavior Therapy', 'Varenicline'], 'conditions': ['Cigarette Smoking', 'Nicotine Dependence', 'Post-traumatic Stress Disorder', 'Tobacco Use Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.med.upenn.edu/ctsa/', 'label': 'Center for the Treatment and Study of Anxiety'}]}, 'descriptionModule': {'briefSummary': 'This study will examine the effect of combining prolonged exposure, a cognitive-behavioral treatment program for post-traumatic stress disorder (PTSD) with medication (varenicline) and counseling treatments for smoking cessation. Subjects will be randomly assigned to a 3-month treatment of either: 1) varenicline and smoking cessation counseling alone, or 2) prolonged exposure, varenicline, and smoking cessation counseling. Assessments will be completed at the end of treatment and 6-month follow-up.\n\nWe hypothesize that, at the end of treatment and at follow-up, abstinence rates and decrease in cigarettes smoked will be greater among participants who receive the combined treatment for both PTSD and smoking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female treatment-seeking cigarette smokers between 18-75 years old who smoke an average of ≥10 cigarettes/day during past year;\n* Current diagnosis of chronic PTSD (symptom duration \\> 3 months) with clinically significant trauma-related symptoms (PSS-I \\>= 20)\n* Live a commutable distance to the University of Pennsylvania and agree to follow-up visits;\n* Agree not to use other forms of smoking cessation treatment or treatment for PTSD during the study period;\n* If taking SRIs or other medications at intake, have been on stable medication and dose regimen for past 3 months and agree to maintain current regimen if possible;\n* Demonstrate the capacity to provide informed consent;\n* Speak and read English.\n\nExclusion Criteria:\n\n* History of drug or alcohol abuse or dependence in past 3 months or any unwillingness to not smoke marijuana during the first 13 weeks of the study;\n* Current and continuing intimate relationship with a physically or sexually abusive partner;\n* Current suicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment;\n* Prior serious suicide attempt, as judged by the evaluator to have a high degree of lethality;\n* Current or past history of psychosis (bipolar disorder or schizophrenia);\n* History of significant cardiovascular disease or uncontrolled hypertension in past 6 months;\n* Women who are pregnant, likely to become pregnant (i.e., sexually active and not using contraception), or nursing.'}, 'identificationModule': {'nctId': 'NCT00937235', 'briefTitle': 'Treatment of Smoking Among Individuals With PTSD', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Treatment of Smoking Among Individuals With PTSD: A Phase II, Randomized Study of Varenicline and Cognitive Behavioral Therapy', 'orgStudyIdInfo': {'id': 'R01DA023507', 'link': 'https://reporter.nih.gov/quickSearch/R01DA023507', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01DA023507', 'link': 'https://reporter.nih.gov/quickSearch/R01DA023507', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Integrated Treatment', 'description': 'Prolonged Exposure + Varenicline + Medication Management Counseling', 'interventionNames': ['Drug: Varenicline', 'Behavioral: Medication Management Counseling', 'Behavioral: Prolonged Exposure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Varenicline', 'description': 'Varenicline + Medication Management Counseling', 'interventionNames': ['Drug: Varenicline', 'Behavioral: Medication Management Counseling']}], 'interventions': [{'name': 'Varenicline', 'type': 'DRUG', 'otherNames': ['Chantix'], 'description': '1 mg tablets, orally, twice daily x 12 weeks', 'armGroupLabels': ['Integrated Treatment', 'Varenicline']}, {'name': 'Medication Management Counseling', 'type': 'BEHAVIORAL', 'description': '15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation', 'armGroupLabels': ['Integrated Treatment', 'Varenicline']}, {'name': 'Prolonged Exposure', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive-Behavioral Therapy'], 'description': '75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders', 'armGroupLabels': ['Integrated Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Edna B Foa, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}