{"protocolSection":{"identificationModule":{"nctId":"NCT01390246","orgStudyIdInfo":{"id":"10-217"},"secondaryIdInfos":[{"id":"R01DA030998","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DA030998"}],"organization":{"fullName":"The University of Texas Medical Branch, Galveston","class":"OTHER"},"briefTitle":"Bupropion for Smoking Cessation During Pregnancy","officialTitle":"Bupropion for Smoking Cessation During Pregnancy"},"statusModule":{"statusVerifiedDate":"2018-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-07"},"primaryCompletionDateStruct":{"date":"2016-12","type":"ACTUAL"},"completionDateStruct":{"date":"2016-12","type":"ACTUAL"},"studyFirstSubmitDate":"2011-06-08","studyFirstSubmitQcDate":"2011-07-06","studyFirstPostDateStruct":{"date":"2011-07-08","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-12-08","resultsFirstSubmitQcDate":"2018-01-16","resultsFirstPostDateStruct":{"date":"2018-02-13","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-06-05","lastUpdatePostDateStruct":{"date":"2019-06-07","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"The University of Texas Medical Branch, Galveston","class":"OTHER"},"collaborators":[{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"},{"name":"UConn Health","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This is a prospective, double-blind placebo-controlled randomized pilot trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy.","detailedDescription":"This is a prospective, double-blind placebo-controlled randomized pilot trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy. A total of 150 pregnant smokers will receive medication (75) or placebo (75) for 12 weeks. Compassionate care/continuance of therapy will be available to pregnant subjects. Women who relapse to smoking postpartum will be offered an additional course of medication treatment. All subjects regardless of adherence with 12 week study drug administration period and smoking habits during pregnancy will be followed through the duration of their pregnancy, delivery, and 6-month postpartum period. Subject participation will begin between 13-30 wks of gestation and end 6 months postpartum. Participation will be ten (10) to thirteen(13) months in length."},"conditionsModule":{"conditions":["Pregnancy Related","Tobacco Use Disorder"],"keywords":["Pregnancy","Tobacco use disorder","Smoking cessation","Bupropion SR","Zyban"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":65,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Bupropion SR + cessation counseling","type":"ACTIVE_COMPARATOR","description":"Bupropion SR and smoking cessation counseling Subjects received Bupropion SR 150 mg tablet orally twice daily (BID) for 12 weeks. Subjects were instructed to begin using study medication (bupropion SR 150 mg orally for 3 days, then BID for 4 days) on study visit day 1, which was approximately 1 week prior to their quit date. Thereafter, they were continued to dose Bupropion SR 150 mg tablet orally BID for a total medication treatment of 12 full weeks.\n\nSmoking cessation counseling included 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the trained study nurse.","interventionNames":["Drug: Bupropion SR","Behavioral: Smoking Cessation Counseling"]},{"label":"Placebo + cessation counseling","type":"PLACEBO_COMPARATOR","description":"Placebo and smoking cessation counseling Subjects received matching Bupropion SR placebo tablet orally twice daily (BID) for 12 weeks. Subjects were instructed to begin using study medication (matched placebo tablets orally for 3 days, then BID for 4 days) on study visit day 1, which was approximately 1 week prior to their quit date. Thereafter, they were continued to dose matching Bupropion SR placebo tablet orally BID for a total medication treatment of 12 full weeks of therapy.\n\nSmoking cessation counseling included 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the trained study nurse.","interventionNames":["Behavioral: Smoking Cessation Counseling","Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Bupropion SR","description":"Bupropion SR 150 mg tablet","armGroupLabels":["Bupropion SR + cessation counseling"],"otherNames":["Zyban","buproban"]},{"type":"BEHAVIORAL","name":"Smoking Cessation Counseling","description":"35-min counseling by trained research nurse","armGroupLabels":["Bupropion SR + cessation counseling","Placebo + cessation counseling"],"otherNames":["Behavioral counseling"]},{"type":"DRUG","name":"Placebo","description":"Matching Bupropion SR placebo tablet","armGroupLabels":["Placebo + cessation counseling"],"otherNames":["Control"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups During Medication Treatment","description":"Cigarette craving and withdrawal symptoms were assessed by the Minnesota Nicotine Withdrawal Scale (MNWS). MNWS consists of 7 objectives (e.g., irritability, anxious, depressed mood, difficulty concentrating, increased appetite, insomnia, restless). Subjects were given a score on each item on a scale of 0 (not present) to 4 (severe). Summed (total) score excluding craving represent subject's symptoms of tobacco withdrawal, ranging from 0 to 28. We calculated a craving for tobacco score and a total score of withdrawal symptoms excluding craving. The higher score represent more sever craving and withdrawal.","timeFrame":"During treatment: Visits 2-6 (time period between 2nd and 12th week of therapy)"},{"measure":"Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups on the Quit Date","description":"Cigarette craving and withdrawal symptoms were assessed by the Minnesota Nicotine Withdrawal Scale (MNWS). MNWS consists of 7 objectives (e.g., irritability, anxious, depressed mood, difficulty concentrating, increased appetite, insomnia, restless). Subjects were given a score on each item on a scale of 0 (not present) to 4 (severe). Summed (total) score excluding craving represent subject's symptoms of tobacco withdrawal, ranging from 0 to 28. We calculated a craving for tobacco score and a total score of withdrawal symptoms excluding craving. The higher score represent more sever craving and withdrawal.","timeFrame":"Quit date, visit 2 (one week after starting the 12-week course of therapy)"},{"measure":"Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Medication Treatment (Visit 6)","description":"The accuracy of self-reported smoking abstinence during study visits was confirmed by an exhaled carbon monoxide (CO) levels and by urinary cotinine levels. 7-day point prevalence abstinence was defined as no cigarettes (not even a puff) in the last 7 days, levels of (CO) in exhaled air \\< 4 ppm, and concentrations of cotinine in urine \\< 50 ng/mL. At every visit, a research nurse monitored the smoking status of all subjects (amount of cigarettes per day, exhaled CO). Exhaled CO was measured using a Vitalograph carbon monoxide monitor (Lenexa, KS) according to the manufacturer's recommendations. A urine sample was collected at each visit and cotinine in urine was quantified using the validated liquid chromatography-mass spectrometry (LC/MS) method. We calculated the total number of abstinent subjects. The higher the number the better outcome.","timeFrame":"Visit 6 (end of 12 weeks of medication therapy)"},{"measure":"Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Pregnancy (Visit 7)","description":"The accuracy of self-reported smoking abstinence during study visits was confirmed by an exhaled carbon monoxide (CO) levels and by urinary cotinine levels. 7-day point prevalence abstinence was defined as no cigarettes (not even a puff) in the last 7 days, levels of (CO) in exhaled air \\< 4 ppm, and concentrations of cotinine in urine \\< 50 ng/mL. At every visit, a research nurse monitored the smoking status of all subjects (amount of cigarettes per day, exhaled CO). Exhaled CO was measured using a Vitalograph carbon monoxide monitor (Lenexa, KS) according to the manufacturer's recommendations. A urine sample was collected at each visit and cotinine in urine was quantified using the validated liquid chromatography-mass spectrometry (LC/MS) method. We calculated the total number of abstinent subjects. The higher the number the better outcome.","timeFrame":"End of pregnancy (visit 7) is a time period between 36.0-38.6 weeks gestation"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* smoking at least 10 CPD prior to pregnancy and 5 CPD for the preceding 7 days\n* 13-30 weeks gestation\n* ≥18 years of age\n* able to speak English or Spanish\n* intent to carry pregnancy to term\n* stable residence\n\nExclusion Criteria:\n\n* current illicit drug or alcohol abuse or dependence\n* twins or other multiple gestation\n* treatment for psychiatric disorder within the last 6 months\n* unstable medical problems (eg, hypertension (BP\\>140/90), preeclampsia, threatened abortion, hyperemesis gravidarum)\n* known congenital abnormality\n* seizure disorder\n* use of psychotropic medication\n* use of medication known to lower the seizure threshold\n* anorexia/bulimia\n* a personal history of closed head trauma with \\> 30 minutes of loss of consciousness or amnesia or resulting in skull fracture or subdural hematoma/brain contusion\n* use of any other smoking cessation treatment in the past 30 days\n* current enrollment in methadone treatment program\n* prior pregnancy with preeclampsia diagnosis\n* chronic hypertension (past history or current diagnosis)","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Gary DV Hankins, MD","affiliation":"The University of Texas Medical Branch, Galveston","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Tatiana Nanovskaya, PhD","affiliation":"The University of Texas Medical Branch, Galveston","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Cheryl Onken, MD, MPH","affiliation":"UConn Health","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Mahmoud Ahmed, PhD","affiliation":"The University of Texas Medical Branch, Galveston","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Shannon Clark, MD","affiliation":"The University of Texas Medical Branch, Galveston","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Texas Medical Branch at Galveston","city":"Galveston","state":"Texas","zip":"77555","country":"United States","geoPoint":{"lat":29.30135,"lon":-94.7977}}]},"referencesModule":{"references":[{"pmid":"27890648","type":"RESULT","citation":"Nanovskaya TN, Oncken C, Fokina VM, Feinn RS, Clark SM, West H, Jain SK, Ahmed MS, Hankins GDV. Bupropion sustained release for pregnant smokers: a randomized, placebo-controlled trial. Am J Obstet Gynecol. 2017 Apr;216(4):420.e1-420.e9. doi: 10.1016/j.ajog.2016.11.1036. Epub 2016 Nov 25."}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"No plan"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Psychological screening using the PRIME MD survey was administered after enrollment at the first Study Visit. Using the score, subjects with evidence of major depression or any other severe, acute psychiatric symptom (eg, psychosis) were considered screen failures and referred back to their prenatal provider for treatment.","recruitmentDetails":"Pregnant smokers were recruited through the UTMB Ob/Gyn Department clinics and Regional Maternal Child Health Program (RMCHP) clinics. The study was also advertised through printed flyers, posters, and electronic media in clinic waiting areas. UTMB OB providers were notified of the study as well to refer potential participants.","groups":[{"id":"FG000","title":"Bupropion SR","description":"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.\n\nSubjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."},{"id":"FG001","title":"Placebo","description":"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.\n\nSubjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"35"}]},{"type":"Visit 2: Quit Day","achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"24"}]},{"type":"Visit 6: End of Treatment","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"Visit 7: 36-38 Weeks Gestation","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"25"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Bupropion SR","description":"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.\n\nSubjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."},{"id":"BG001","title":"Placebo","description":"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.\n\nSubjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"65"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"65"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"24.5","spread":"5.56"},{"groupId":"BG001","value":"27.5","spread":"6.52"},{"groupId":"BG002","value":"26.2","spread":"6.2"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"65"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"9"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"55"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"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":"3"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"16"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"49"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"65"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups During Medication Treatment","description":"Cigarette craving and withdrawal symptoms were assessed by the Minnesota Nicotine Withdrawal Scale (MNWS). MNWS consists of 7 objectives (e.g., irritability, anxious, depressed mood, difficulty concentrating, increased appetite, insomnia, restless). Subjects were given a score on each item on a scale of 0 (not present) to 4 (severe). Summed (total) score excluding craving represent subject's symptoms of tobacco withdrawal, ranging from 0 to 28. We calculated a craving for tobacco score and a total score of withdrawal symptoms excluding craving. The higher score represent more sever craving and withdrawal.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"MNWS Score","timeFrame":"During treatment: Visits 2-6 (time period between 2nd and 12th week of therapy)","groups":[{"id":"OG000","title":"Bupropion SR","description":"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.\n\nSubjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."},{"id":"OG001","title":"Placebo","description":"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.\n\nSubjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"24"}]}],"classes":[{"title":"Craving for tobacco","categories":[{"measurements":[{"groupId":"OG000","value":"1.50","spread":"1.11"},{"groupId":"OG001","value":"2.07","spread":"1.23"}]}]},{"title":"Total score of withdrawal excluding craving","categories":[{"measurements":[{"groupId":"OG000","value":"3.77","spread":"4.27"},{"groupId":"OG001","value":"5.35","spread":"5.14"}]}]}]},{"type":"PRIMARY","title":"Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups on the Quit Date","description":"Cigarette craving and withdrawal symptoms were assessed by the Minnesota Nicotine Withdrawal Scale (MNWS). MNWS consists of 7 objectives (e.g., irritability, anxious, depressed mood, difficulty concentrating, increased appetite, insomnia, restless). Subjects were given a score on each item on a scale of 0 (not present) to 4 (severe). Summed (total) score excluding craving represent subject's symptoms of tobacco withdrawal, ranging from 0 to 28. We calculated a craving for tobacco score and a total score of withdrawal symptoms excluding craving. The higher score represent more sever craving and withdrawal.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"MNWS Score","timeFrame":"Quit date, visit 2 (one week after starting the 12-week course of therapy)","groups":[{"id":"OG000","title":"Bupropion SR","description":"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.\n\nSubjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."},{"id":"OG001","title":"Placebo","description":"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.\n\nSubjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"24"}]}],"classes":[{"title":"Craving for tobacco","categories":[{"measurements":[{"groupId":"OG000","value":"2.04","spread":"1.08"},{"groupId":"OG001","value":"2.33","spread":"1.31"}]}]},{"title":"Total score of withdrawal excluding craving","categories":[{"measurements":[{"groupId":"OG000","value":"4.75","spread":"4.87"},{"groupId":"OG001","value":"4.88","spread":"4.61"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Medication Treatment (Visit 6)","description":"The accuracy of self-reported smoking abstinence during study visits was confirmed by an exhaled carbon monoxide (CO) levels and by urinary cotinine levels. 7-day point prevalence abstinence was defined as no cigarettes (not even a puff) in the last 7 days, levels of (CO) in exhaled air \\< 4 ppm, and concentrations of cotinine in urine \\< 50 ng/mL. At every visit, a research nurse monitored the smoking status of all subjects (amount of cigarettes per day, exhaled CO). Exhaled CO was measured using a Vitalograph carbon monoxide monitor (Lenexa, KS) according to the manufacturer's recommendations. A urine sample was collected at each visit and cotinine in urine was quantified using the validated liquid chromatography-mass spectrometry (LC/MS) method. We calculated the total number of abstinent subjects. The higher the number the better outcome.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Visit 6 (end of 12 weeks of medication therapy)","groups":[{"id":"OG000","title":"Bupropion SR","description":"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.\n\nSubjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."},{"id":"OG001","title":"Placebo","description":"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.\n\nSubjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"35"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"1"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Pregnancy (Visit 7)","description":"The accuracy of self-reported smoking abstinence during study visits was confirmed by an exhaled carbon monoxide (CO) levels and by urinary cotinine levels. 7-day point prevalence abstinence was defined as no cigarettes (not even a puff) in the last 7 days, levels of (CO) in exhaled air \\< 4 ppm, and concentrations of cotinine in urine \\< 50 ng/mL. At every visit, a research nurse monitored the smoking status of all subjects (amount of cigarettes per day, exhaled CO). Exhaled CO was measured using a Vitalograph carbon monoxide monitor (Lenexa, KS) according to the manufacturer's recommendations. A urine sample was collected at each visit and cotinine in urine was quantified using the validated liquid chromatography-mass spectrometry (LC/MS) method. We calculated the total number of abstinent subjects. The higher the number the better outcome.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"End of pregnancy (visit 7) is a time period between 36.0-38.6 weeks gestation","groups":[{"id":"OG000","title":"Bupropion SR","description":"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.\n\nSubjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."},{"id":"OG001","title":"Placebo","description":"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.\n\nSubjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"35"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge.","description":"We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \\>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \\<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\\<10%), Apgar scores \\<7 at 5 minutes, and neonatal length of hospital stay \\>3 days.","eventGroups":[{"id":"EG000","title":"Bupropion SR","description":"Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.\n\nSubjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.","deathsNumAffected":0,"deathsNumAtRisk":30,"seriousNumAffected":2,"seriousNumAtRisk":30,"otherNumAffected":14,"otherNumAtRisk":30},{"id":"EG001","title":"Placebo","description":"Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.\n\nSubjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.","deathsNumAffected":0,"deathsNumAtRisk":35,"seriousNumAffected":5,"seriousNumAtRisk":35,"otherNumAffected":8,"otherNumAtRisk":35}],"seriousEvents":[{"term":"Infant stay in NICU >3 days due to premature delivery","organSystem":"Pregnancy, puerperium and perinatal conditions","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":4,"numAtRisk":35}]},{"term":"Preeclampsia","organSystem":"Pregnancy, puerperium and perinatal conditions","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":35}]},{"term":"Cord blood pH <7.01","organSystem":"Pregnancy, puerperium and perinatal conditions","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":35}]},{"term":"Gestational Diabetes","organSystem":"Pregnancy, puerperium and perinatal conditions","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":35}]}],"otherEvents":[{"term":"Headache","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":30},{"groupId":"EG001","numAffected":6,"numAtRisk":35}]},{"term":"Difficulty sleeping","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":30},{"groupId":"EG001","numAffected":7,"numAtRisk":35}]},{"term":"Rhinorhea- Runny Nose","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":30},{"groupId":"EG001","numAffected":8,"numAtRisk":35}]},{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":30},{"groupId":"EG001","numAffected":7,"numAtRisk":35}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":30},{"groupId":"EG001","numAffected":6,"numAtRisk":35}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Factors affecting enrollment included social stigma of prenatal smoking and use of medications; high rate of early withdrawal/lost to follow since longitudinal"},"certainAgreement":{"piSponsorEmployee":true,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Tatiana Nanovskaya, PhD","organization":"University of Texas Medical Branch","email":"tnnanovs@utmb.edu","phone":"409-772-3908"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D014029","term":"Tobacco Use Disorder"},{"id":"D016540","term":"Smoking Cessation"}],"ancestors":[{"id":"D019966","term":"Substance-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D015438","term":"Health Behavior"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D016642","term":"Bupropion"},{"id":"D001521","term":"Behavior Therapy"}],"ancestors":[{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D011613","term":"Psychotherapy"},{"id":"D004191","term":"Behavioral Disciplines and Activities"}]}},"hasResults":true}