Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-25 @ 3:26 PM
Study NCT ID:
NCT01592695
Status:
COMPLETED
Last Update Posted:
2019-08-02
First Post:
2012-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tailored Tobacco Quitline for Rural Veterans
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': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001835', 'term': 'Body Weight'}], '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': 'D015438', 'term': 'Health Behavior'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016642', 'term': 'Bupropion'}, {'id': 'D000068580', 'term': 'Varenicline'}, {'id': 'D000074164', 'term': 'Nicotine Chewing Gum'}, {'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D000431', 'term': 'Ethanol'}], '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'}, {'id': 'D002638', 'term': 'Chewing Gum'}, {'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002182', 'term': 'Candy'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D000438', 'term': 'Alcohols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mark-vanderweg@uiowa.edu', 'phone': '319-338-0581', 'title': 'Mark Vander Weg, PhD', 'phoneExt': '7717', 'organization': 'University of Iowa'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Six months', 'description': "Data regarding adverse events were collected via self-report and information provided in patients' electronic medical record.", 'eventGroups': [{'id': 'EG000', 'title': 'Tailored Intervention Group', 'description': 'Participants will receive a combined behavioral and pharmacological intervention.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Enhanced Standard of Care Group', 'description': "Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.\n\nTobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence.", 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention Group', 'description': 'Participants will receive a combined behavioral and pharmacological intervention.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care Group', 'description': "Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.\n\nTobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."}], 'classes': [{'title': 'Found treatment very or extremely useful', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Found medication to be very or extremely useful', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Found treatment to be very or extremely convenient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Found treatment to be very or extremely difficult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Liked that treatment was delivered by phone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of treatment (seven weeks after baseline)', 'description': "Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed treatment satisfaction items on three-month follow-up'}, {'type': 'SECONDARY', 'title': 'Number of Participants Abstinent From Tobacco Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention Group', 'description': 'Participants will receive a combined behavioral and pharmacological intervention.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care Group', 'description': "Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.\n\nTobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Six-month follow-up', 'description': 'At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '7-day point prevalence abstinence at 6 months. Those with missing data treated as smokers (penalized imputation).'}, {'type': 'SECONDARY', 'title': 'Alcohol Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention Group', 'description': 'Participants will receive a combined behavioral and pharmacological intervention.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care Group', 'description': "Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.\n\nTobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six-month follow-up', 'description': 'Alcohol use during the previous seven days will be assessed among those receiving the risky alcohol use treatment module and those in the quitline referral condition who would have been eligible for the intervention if assigned to the tailored treatment group.', 'unitOfMeasure': 'Drinks consumed per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the tailored intervention group who received the alcohol intervention and those in the enhanced standard of care group who would have been eligible for the alcohol intervention if they had been assigned to the tailored intervention group.'}, {'type': 'SECONDARY', 'title': 'Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention Group', 'description': 'Participants will receive a combined behavioral and pharmacological intervention.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care Group', 'description': "Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.\n\nTobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six-month follow-up', 'description': 'Depressive symptoms as measured using the Patient Health Questionnaire 9 (PHQ-9). Possible scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the tailored intervention group who receive the mood management module and those in the enhanced standard of care condition who would have been eligible for the mood management module if they had been assigned to the tailored intervention condition.'}, {'type': 'SECONDARY', 'title': 'Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention Group', 'description': 'Participants will receive a combined behavioral and pharmacological intervention.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care Group', 'description': "Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.\n\nTobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."}], 'classes': [{'categories': [{'measurements': [{'value': '214.0', 'spread': '38.1', 'groupId': 'OG000'}, {'value': '228.2', 'spread': '45.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six-month follow-up', 'description': 'Self-reported body weight.', 'unitOfMeasure': 'Pounds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Assessed among participants in the tailored intervention group who received the weight management module and those in the enhanced standard of care condition who would have been eligible for the weight management module if they had been assigned to the tailored intervention condition.'}, {'type': 'SECONDARY', 'title': 'Enrollment Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention Group', 'description': 'Participants will receive a combined behavioral and pharmacological intervention.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care Group', 'description': "Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.\n\nTobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after study initiation', 'description': 'The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approached for the entire six-month recruitment period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of participants randomized to each treatment condition.'}, {'type': 'SECONDARY', 'title': 'Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention Group', 'description': 'Participants will receive a combined behavioral and pharmacological intervention.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of treatment (seven weeks after baseline)', 'description': 'The number of participants who remain in the study throughout the seven-week treatment period will be computed as an indicator of the feasibility of the treatment approach.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants assigned to the tailored intervention condition who completed the intervention calls.'}, {'type': 'SECONDARY', 'title': 'Treatment Attendance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention Group', 'description': 'Participants will receive a combined behavioral and pharmacological intervention.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of treatment (seven weeks after baseline)', 'description': 'The number of treatment calls completed (out of six total) will be calculated for all participants in the Tailored Intervention group as an indicator of the feasibility of the treatment approach.', 'unitOfMeasure': 'Calls', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Attendance rate (number of counseling calls completed out of 6) among those assigned to the tailored intervention condition.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tailored Intervention Group', 'description': 'Participants will receive a combined behavioral and pharmacological intervention.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.\n\nTailored behavioral intervention: Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules treatment modules to address common issues associated with cigarette smoking based on individual need and preference. Individual treatment models address alcohol risk reduction, elevated depressive symptoms, and concerns about weight gain.'}, {'id': 'FG001', 'title': 'Enhanced Standard of Care Group', 'description': "Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.\n\nTobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tailored Intervention Group', 'description': 'Participants will receive a combined behavioral and pharmacological intervention.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.'}, {'id': 'BG001', 'title': 'Enhanced Standard of Care Group', 'description': "Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.\n\nPharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.\n\nTobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence."}, {'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': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.1', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '58.5', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '56.8', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Nicotine dependence', 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '5.7', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '5.7', 'spread': '2.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Possible scores range from 0 to 11. Higher scores indicate greater levels of nicotine dependence.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cigarettes smoked per day', 'classes': [{'categories': [{'measurements': [{'value': '22.3', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '27.2', 'spread': '25.7', 'groupId': 'BG001'}, {'value': '24.7', 'spread': '19.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cigarettes/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Prior quit attempts lasting at least 24 hours', 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '9.4', 'spread': '19.6', 'groupId': 'BG001'}, {'value': '8.0', 'spread': '15.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'quit attempts', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Readiness to quit smoking', 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '6.5', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '6.6', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Scores range from 1 to 10, with higher scores indicating greater readiness to quit smoking.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age of smoking initiation', 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '15.8', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '16.2', 'spread': '3.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-20', 'studyFirstSubmitDate': '2012-04-11', 'resultsFirstSubmitDate': '2017-04-14', 'studyFirstSubmitQcDate': '2012-05-03', 'lastUpdatePostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-20', 'studyFirstPostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Satisfaction', 'timeFrame': 'End of treatment (seven weeks after baseline)', 'description': "Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment."}], 'secondaryOutcomes': [{'measure': 'Number of Participants Abstinent From Tobacco Use', 'timeFrame': 'Six-month follow-up', 'description': 'At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence).'}, {'measure': 'Alcohol Use', 'timeFrame': 'Six-month follow-up', 'description': 'Alcohol use during the previous seven days will be assessed among those receiving the risky alcohol use treatment module and those in the quitline referral condition who would have been eligible for the intervention if assigned to the tailored treatment group.'}, {'measure': 'Depressive Symptoms', 'timeFrame': 'Six-month follow-up', 'description': 'Depressive symptoms as measured using the Patient Health Questionnaire 9 (PHQ-9). Possible scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms.'}, {'measure': 'Body Weight', 'timeFrame': 'Six-month follow-up', 'description': 'Self-reported body weight.'}, {'measure': 'Enrollment Rate', 'timeFrame': '6 months after study initiation', 'description': 'The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approached for the entire six-month recruitment period.'}, {'measure': 'Retention', 'timeFrame': 'End of treatment (seven weeks after baseline)', 'description': 'The number of participants who remain in the study throughout the seven-week treatment period will be computed as an indicator of the feasibility of the treatment approach.'}, {'measure': 'Treatment Attendance', 'timeFrame': 'End of treatment (seven weeks after baseline)', 'description': 'The number of treatment calls completed (out of six total) will be calculated for all participants in the Tailored Intervention group as an indicator of the feasibility of the treatment approach.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nicotine dependence', 'Smoking cessation', 'Telehealth', 'Alcohol use', 'Depression', 'Body weight'], 'conditions': ['Cigarette Smoking']}, 'referencesModule': {'references': [{'pmid': '27535024', 'type': 'RESULT', 'citation': 'Vander Weg MW, Cozad AJ, Howren MB, Cretzmeyer M, Scherubel M, Turvey C, Grant KM, Abrams TE, Katz DA. An individually-tailored smoking cessation intervention for rural Veterans: a pilot randomized trial. BMC Public Health. 2016 Aug 17;16(1):811. doi: 10.1186/s12889-016-3493-z.'}, {'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.'}]}, 'descriptionModule': {'briefSummary': 'The proposed work is designed to help increase access to tobacco cessation services among rural veterans and to develop more effective treatment services that better address comorbid issues commonly experienced by rural smokers. The objectives are:\n\n1. Study the feasibility of an individually-tailored telephone intervention for rural smokers.\n2. Examine the impact of the intervention on tobacco use outcomes.\n3. Evaluate the effect of the intervention on issues commonly experienced by rural smokers including depressive symptoms, alcohol use, and weight gain.', 'detailedDescription': "Tobacco use remains the leading preventable cause of morbidity and mortality in our society. Results from epidemiologic studies indicate that tobacco use is especially elevated among those living in rural areas. Although interventions exist that are both effective and cost-effective, few rural smokers utilize them during any given quit attempt. A lack of local treatment resources, the travel distance required to obtain treatment, and a reduced tendency to visit primary care on a regular basis all appear to contribute to the lower levels of treatment for nicotine dependence in rural smokers.\n\nSmokers frequently experience conditions and concerns that adversely impact their ability to quit smoking. Depression and risky alcohol use, both of which are prevalent among smokers, reduce the likelihood of successfully quitting smoking. Concern about gaining weight, a common consequence of quitting smoking, is also frequently cited by smokers as an important barrier to quitting. Therefore, in order to be most effective, tobacco cessation interventions will need to address these important issues. Presently, treatment for nicotine dependence, risky alcohol use, depression, and weight management is typically delivered separately and without optimal integration among providers, an approach which only serves to fragment care and increase the number of required visits, further reduce rural smokers' access to care.\n\nIn an effort to address these barriers, the current study will evaluate a telephone intervention for tobacco use that also addresses issues related to risky alcohol use, depressed mood, and postcessation weight gain based on each individual smoker's needs. Results will provide valuable information regarding the potential to more widely implement an individually-tailored telephone intervention for rural smokers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being a veteran\n* 18 + years of age\n* Smoke cigarettes on at least a daily basis\n* Receive primary care from the Iowa City VAMC or Coralville Clinic\n* Live in a non-metropolitan area (based on RUCA codes)\n* Be willing to make a quit attempt in the next 30 days\n* Be capable of providing informed consent\n* Have access to a telephone (land line or cell phone)\n* Have a stable residence\n\nExclusion Criteria:\n\n* Planning to move within the next 12 months\n* Presence of a terminal illness\n* Pregnancy\n* Unstable psychiatric disorder (e.g., acute psychosis)\n* Currently pregnant\n* Incarcerated\n* Institutionalized'}, 'identificationModule': {'nctId': 'NCT01592695', 'briefTitle': 'Tailored Tobacco Quitline for Rural Veterans', 'organization': {'class': 'FED', 'fullName': 'Iowa City Veterans Affairs Medical Center'}, 'officialTitle': 'Tailored Tobacco Cessation Program for Rural Veterans With Comorbid Depression, Alcoholism or Obesity', 'orgStudyIdInfo': {'id': '201203712'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tailored Intervention Group', 'description': 'Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues associated with cigarette smoking.', 'interventionNames': ['Drug: Nicotine replacement therapy - transdermal nicotine patch', 'Behavioral: Tailored behavioral intervention', 'Drug: Nicotine replacement therapy - nicotine gum', 'Drug: Nicotine replacement therapy - nicotine lozenge', 'Drug: Bupropion Sustained Release', 'Drug: Varenicline', 'Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum', 'Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge', 'Drug: Combination pharmacotherapy - transdermal nicotine patch + bupropion', 'Behavioral: Alcohol use risk reduction', 'Behavioral: Behavioral activation for the treatment of depression', 'Behavioral: Behavioral management of post-cessation weight gain']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Standard of Care Group', 'description': 'Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.', 'interventionNames': ['Drug: Nicotine replacement therapy - transdermal nicotine patch', 'Behavioral: Tobacco quit line referral', 'Drug: Nicotine replacement therapy - nicotine gum', 'Drug: Nicotine replacement therapy - nicotine lozenge', 'Drug: Bupropion Sustained Release', 'Drug: Varenicline', 'Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum', 'Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge', 'Drug: Combination pharmacotherapy - transdermal nicotine patch + bupropion']}], 'interventions': [{'name': 'Nicotine replacement therapy - transdermal nicotine patch', 'type': 'DRUG', 'description': 'Medication selection will be determined based on individual participant preferences, medical history, and contraindications.', 'armGroupLabels': ['Enhanced Standard of Care Group', 'Tailored Intervention Group']}, {'name': 'Tailored behavioral intervention', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference.', 'armGroupLabels': ['Tailored Intervention Group']}, {'name': 'Tobacco quit line referral', 'type': 'BEHAVIORAL', 'description': "Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence.", 'armGroupLabels': ['Enhanced Standard of Care Group']}, {'name': 'Nicotine replacement therapy - nicotine gum', 'type': 'DRUG', 'description': 'Medication selection will be determined based on individual participant preferences, medical history, and contraindications', 'armGroupLabels': ['Enhanced Standard of Care Group', 'Tailored Intervention Group']}, {'name': 'Nicotine replacement therapy - nicotine lozenge', 'type': 'DRUG', 'description': 'Medication selection will be determined based on individual participant preferences, medical history, and contraindications', 'armGroupLabels': ['Enhanced Standard of Care Group', 'Tailored Intervention Group']}, {'name': 'Bupropion Sustained Release', 'type': 'DRUG', 'otherNames': ['Zyban'], 'description': 'Medication selection will be determined based on individual participant preferences, medical history, and contraindications', 'armGroupLabels': ['Enhanced Standard of Care Group', 'Tailored Intervention Group']}, {'name': 'Varenicline', 'type': 'DRUG', 'otherNames': ['Chantix'], 'description': 'Medication selection will be determined based on individual participant preferences, medical history, and contraindications', 'armGroupLabels': ['Enhanced Standard of Care Group', 'Tailored Intervention Group']}, {'name': 'Combination pharmacotherapy - transdermal nicotine patch + nicotine gum', 'type': 'DRUG', 'description': 'Medication selection will be determined based on individual participant preferences, medical history, and contraindications', 'armGroupLabels': ['Enhanced Standard of Care Group', 'Tailored Intervention Group']}, {'name': 'Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge', 'type': 'DRUG', 'description': 'Medication selection will be determined based on individual participant preferences, medical history, and contraindications', 'armGroupLabels': ['Enhanced Standard of Care Group', 'Tailored Intervention Group']}, {'name': 'Combination pharmacotherapy - transdermal nicotine patch + bupropion', 'type': 'DRUG', 'description': 'Medication selection will be determined based on individual participant preferences, medical history, and contraindications', 'armGroupLabels': ['Enhanced Standard of Care Group', 'Tailored Intervention Group']}, {'name': 'Alcohol use risk reduction', 'type': 'BEHAVIORAL', 'otherNames': ['Risky alcohol use', 'Harm reduction'], 'description': 'Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.', 'armGroupLabels': ['Tailored Intervention Group']}, {'name': 'Behavioral activation for the treatment of depression', 'type': 'BEHAVIORAL', 'otherNames': ['Depression'], 'description': 'Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.', 'armGroupLabels': ['Tailored Intervention Group']}, {'name': 'Behavioral management of post-cessation weight gain', 'type': 'BEHAVIORAL', 'otherNames': ['Weight management'], 'description': 'Participants with concerns about gaining weight after quitting smoking may receive this six-session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain.', 'armGroupLabels': ['Tailored Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52246', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa City VA Health Care System', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Mark VanderWeg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VRHRC-CR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iowa City Veterans Affairs Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'US Department of Veterans Affairs', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Specialist', 'investigatorFullName': 'Mark Vander Weg', 'investigatorAffiliation': 'Iowa City Veterans Affairs Medical Center'}}}}