{"protocolSection":{"identificationModule":{"nctId":"NCT02420015","orgStudyIdInfo":{"id":"Pro00061683"},"organization":{"fullName":"Duke University","class":"OTHER"},"briefTitle":"Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia","officialTitle":"Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia"},"statusModule":{"statusVerifiedDate":"2019-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-03-27","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-01-24","type":"ACTUAL"},"completionDateStruct":{"date":"2019-01-24","type":"ACTUAL"},"studyFirstSubmitDate":"2015-04-14","studyFirstSubmitQcDate":"2015-04-14","studyFirstPostDateStruct":{"date":"2015-04-17","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-06-19","resultsFirstSubmitQcDate":"2019-06-19","resultsFirstPostDateStruct":{"date":"2019-07-10","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-06-19","lastUpdatePostDateStruct":{"date":"2019-07-10","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Duke University","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study is designed to evaluate if a treatment the investigators call iCOMMIT is effective at helping smokers with schizophrenia stop smoking. iCOMMIT is a smoking cessation treatment that combines mobile technology with behavioral strategies, counseling, and medications.","detailedDescription":"The purpose of this 2-arm randomized controlled trial (RCT) is to evaluate the efficacy of Multi-Component Mobile-enhanced Treatment for Smoking Cessation (iCOMMIT) in helping individuals with schizophrenia or other psychotic disorders stop smoking. Eligible participants will be randomized to receive iCOMMIT, which includes smoking cessation counseling, pharmacotherapy, and mobile technology components, or a control intervention that includes smoking cessation counseling and pharmacotherapy, but no mobile technology components. The control condition represents an intensive standard of care and helps control for monitoring, counselor, time, and attention effects.\n\nThe primary outcome for the study will be self-reported and bio-verified prolonged smoking abstinence at the 6-month follow-up. Self-reported prolonged abstinence will be verified by saliva cotinine assay. Secondary outcomes will include 7- and 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 or 30 days."},"conditionsModule":{"conditions":["Schizophrenia","Cigarette Smoking"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":35,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"iCOMMIT","type":"EXPERIMENTAL","description":"The components of the intervention include 1) behavioral therapy in the form of mobile contingency management (mCM) designed to increase early abstinent rates; 2) pharmacotherapy for smoking cessation \\[including nicotine replacement therapy (NRT) and bupropion\\]; 3) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation; 4) a smart-phone based relapse prevention application (the Stay Quit Coach) that is populated during the counseling sessions; and 5) SMS text messaging reminders to increase medication adherence.","interventionNames":["Drug: Nicotine replacement therapy","Drug: Bupropion","Behavioral: cognitive-behavioral smoking cessation counseling","Behavioral: Mobile Contingency Management","Behavioral: Stay Quit Coach","Behavioral: SMS text messaging"]},{"label":"Control Group","type":"ACTIVE_COMPARATOR","description":"The components of the intervention include 1) pharmacotherapy for smoking cessation \\[including nicotine replacement therapy (NRT) and bupropion\\]; and 2) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation.","interventionNames":["Drug: Nicotine replacement therapy","Drug: Bupropion","Behavioral: cognitive-behavioral smoking cessation counseling"]}],"interventions":[{"type":"DRUG","name":"Nicotine replacement therapy","description":"Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum, nicotine inhaler, or nicotine nasal spray, and will be instructed to use the rescue method as needed to reduce cigarette cravings","armGroupLabels":["Control Group","iCOMMIT"],"otherNames":["nicotine gum, patch, inhaler, and/or lozenge"]},{"type":"DRUG","name":"Bupropion","description":"All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 3-month follow-up","armGroupLabels":["Control Group","iCOMMIT"],"otherNames":["Zyban"]},{"type":"BEHAVIORAL","name":"cognitive-behavioral smoking cessation counseling","description":"Participants will receive four 20-minute smoking cessation counseling sessions and a participant manual. The four sessions are based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation.","armGroupLabels":["Control Group","iCOMMIT"]},{"type":"BEHAVIORAL","name":"Mobile Contingency Management","description":"Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for videos that suggest smoking abstinence.","armGroupLabels":["iCOMMIT"],"otherNames":["mCM"]},{"type":"BEHAVIORAL","name":"Stay Quit Coach","description":"Stay Quit Coach is a smart phone application that serves as a source of readily available support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. The app guides user in creating tailored plans that include their personal reasons for quitting, interactive tools to help users cope with urges to smoke, motivational messages, support contacts to help users stay smoke free and how to address lapses. Participants assigned to this condition will be asked to use Stay Quit Coach from Session 2 through the 6-month follow-up.","armGroupLabels":["iCOMMIT"]},{"type":"BEHAVIORAL","name":"SMS text messaging","description":"Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt, including messages reminding participants to take their smoking cessation medication.","armGroupLabels":["iCOMMIT"],"otherNames":["texting"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants Who Self-report Prolonged Abstinence","description":"Prolonged abstinence will exclude tobacco use in the first two weeks following the quit date, as is consistent with other smoking cessation trials.","timeFrame":"6 month follow-up"},{"measure":"Number of Participants Whose Prolonged Abstinence is Bio-verified","description":"Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence at each follow-up.","timeFrame":"6 month follow-up"}],"secondaryOutcomes":[{"measure":"Number of Participants Who Report 7 Day Point Prevalence Abstinence","description":"Secondary smoking outcomes will include 7-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 days.","timeFrame":"3 months post-quit attempt (Session 5)"},{"measure":"Number of Participants Who Report 30 Day Point Prevalence Abstinence","description":"Secondary smoking outcomes will include 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 30 days.","timeFrame":"3 months post-quit attempt (Session 5)"},{"measure":"Number of Participants Who Report 7 Day Point Prevalence Abstinence","description":"Secondary smoking outcomes will include 7-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 days.","timeFrame":"6 months post-quit attempt (Session 6)"},{"measure":"Number of Participants Who Report 30 Day Point Prevalence Abstinence","description":"Secondary smoking outcomes will include 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 30 days.","timeFrame":"6 months post-quit attempt (Session 6)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Currently smoke at least ten cigarettes a day\n* Have been smoking for at least one year\n* Meet criteria for schizophrenia, schizoaffective disorder, or another psychotic disorder based on structured clinical interview\n* Can speak and write fluent conversational English\n* Are between 18 and 70 years of age\n* Are willing to make a smoking cessation attempt\n* Score 26 or higher on the Montreal Cognitive Assessment\n\nExclusion Criteria:\n\n* Have a history of myocardial infarction in the past 6 months\n* Have a contraindication to NRT with no medical clearance from the primary care provider or study physician\n* Use and unwillingness to stop use of other forms of nicotine such as cigars, pipes, or chewing tobacco\n* Are pregnant\n* Meet criteria for a current manic episode based on structured clinical interview\n* Are currently enrolled in another smoking cessation trial\n* Are currently imprisoned or in psychiatric hospitalization","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Jean C Beckham, Ph.D.","affiliation":"Duke University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","zip":"27706","country":"United States","geoPoint":{"lat":35.99403,"lon":-78.89862}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"One participant was deemed ineligible to participate in the study prior to randomization because that participant couldn't read or write English.","groups":[{"id":"FG000","title":"iCOMMIT","description":"Components include:\n\n1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.\n2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n3. 4 sessions cognitive-behavioral smoking cessation counseling;\n4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.\n5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt."},{"id":"FG001","title":"Control Group","description":"Components include:\n\n1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n2. 4 sessions cognitive-behavioral smoking cessation counseling;"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"13"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"13"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"iCOMMIT","description":"Components include:\n\n1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.\n2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n3. 4 sessions cognitive-behavioral smoking cessation counseling;\n4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.\n5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt."},{"id":"BG001","title":"Control Group","description":"Components include:\n\n1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n2. 4 sessions cognitive-behavioral smoking cessation counseling;"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"34"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"49.24","spread":"10.30"},{"groupId":"BG001","value":"46.92","spread":"10.30"},{"groupId":"BG002","value":"48.39","spread":"10.20"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"10"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"24"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"33"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"19"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"34"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants Who Self-report Prolonged Abstinence","description":"Prolonged abstinence will exclude tobacco use in the first two weeks following the quit date, as is consistent with other smoking cessation trials.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"6 month follow-up","groups":[{"id":"OG000","title":"iCOMMIT","description":"Components include:\n\n1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.\n2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n3. 4 sessions cognitive-behavioral smoking cessation counseling;\n4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.\n5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt."},{"id":"OG001","title":"Control Group","description":"Components include:\n\n1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n2. 4 sessions cognitive-behavioral smoking cessation counseling;"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"}]}]}]},{"type":"PRIMARY","title":"Number of Participants Whose Prolonged Abstinence is Bio-verified","description":"Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence at each follow-up.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"6 month follow-up","groups":[{"id":"OG000","title":"iCOMMIT","description":"Components include:\n\n1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.\n2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n3. 4 sessions cognitive-behavioral smoking cessation counseling;\n4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.\n5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt."},{"id":"OG001","title":"Control Group","description":"Components include:\n\n1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n2. 4 sessions cognitive-behavioral smoking cessation counseling;"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Report 7 Day Point Prevalence Abstinence","description":"Secondary smoking outcomes will include 7-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 days.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"3 months post-quit attempt (Session 5)","groups":[{"id":"OG000","title":"iCOMMIT","description":"Components include:\n\n1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.\n2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n3. 4 sessions cognitive-behavioral smoking cessation counseling;\n4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.\n5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt."},{"id":"OG001","title":"Control Group","description":"Components include:\n\n1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n2. 4 sessions cognitive-behavioral smoking cessation counseling;"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Report 30 Day Point Prevalence Abstinence","description":"Secondary smoking outcomes will include 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 30 days.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"3 months post-quit attempt (Session 5)","groups":[{"id":"OG000","title":"iCOMMIT","description":"Components include:\n\n1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.\n2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n3. 4 sessions cognitive-behavioral smoking cessation counseling;\n4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.\n5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt."},{"id":"OG001","title":"Control Group","description":"Components include:\n\n1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n2. 4 sessions cognitive-behavioral smoking cessation counseling;"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Report 7 Day Point Prevalence Abstinence","description":"Secondary smoking outcomes will include 7-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 days.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"6 months post-quit attempt (Session 6)","groups":[{"id":"OG000","title":"iCOMMIT","description":"Components include:\n\n1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.\n2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n3. 4 sessions cognitive-behavioral smoking cessation counseling;\n4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.\n5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt."},{"id":"OG001","title":"Control Group","description":"Components include:\n\n1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n2. 4 sessions cognitive-behavioral smoking cessation counseling;"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Report 30 Day Point Prevalence Abstinence","description":"Secondary smoking outcomes will include 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 30 days.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"6 months post-quit attempt (Session 6)","groups":[{"id":"OG000","title":"iCOMMIT","description":"Components include:\n\n1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.\n2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n3. 4 sessions cognitive-behavioral smoking cessation counseling;\n4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.\n5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt."},{"id":"OG001","title":"Control Group","description":"Components include:\n\n1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n2. 4 sessions cognitive-behavioral smoking cessation counseling;"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).","eventGroups":[{"id":"EG000","title":"iCOMMIT","description":"Components include:\n\n1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.\n2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n3. 4 sessions cognitive-behavioral smoking cessation counseling;\n4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.\n5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.","deathsNumAffected":0,"deathsNumAtRisk":21,"seriousNumAffected":2,"seriousNumAtRisk":21,"otherNumAffected":13,"otherNumAtRisk":21},{"id":"EG001","title":"Control Group","description":"Components include:\n\n1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \\[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)\n2. 4 sessions cognitive-behavioral smoking cessation counseling;","deathsNumAffected":0,"deathsNumAtRisk":13,"seriousNumAffected":3,"seriousNumAtRisk":13,"otherNumAffected":12,"otherNumAtRisk":13}],"seriousEvents":[{"term":"Hospitalization","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":21},{"groupId":"EG001","numEvents":4,"numAffected":3,"numAtRisk":13}]}],"otherEvents":[{"term":"Suicidal ideation","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":21},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":13}]},{"term":"Mouth and/or throat irritation","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"study-related","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":21},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":13}]},{"term":"Altercation with police","organSystem":"Social circumstances","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":21},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":13}]},{"term":"Jitteriness, shakiness","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Related to bupropion use","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":21},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":13}]},{"term":"Sleep problems and/or nightmares","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":21},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":13}]},{"term":"Skin irritation","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Related to nicotine patch use","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":21},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":13}]},{"term":"Sweating","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Related to quitting smoking","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":21},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":13}]},{"term":"Family violence","organSystem":"Social circumstances","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Not related to study participation","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":21},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":13}]},{"term":"Rape","organSystem":"Social circumstances","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Not related to study 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