A Phase 4 interventional study of Bupropion SR and Smoking Cessation Counseling in Pregnancy Related and Tobacco Use Disorder, sponsored by The University of Texas Medical Branch, Galveston. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-07.
Sponsored by The University of Texas Medical Branch, Galveston · Phase 4, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
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. Smoking 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.
Drug: Bupropion SR · Behavioral: Smoking Cessation Counseling
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. Smoking 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.
Behavioral: Smoking Cessation Counseling · Drug: Placebo
Bupropion SR 150 mg tablet
Also known as: Zyban, buproban
35-min counseling by trained research nurse
Also known as: Behavioral counseling
Matching Bupropion SR placebo tablet
Also known as: Control
Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups During Medication Treatment
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.
Time frame: During treatment: Visits 2-6 (time period between 2nd and 12th week of therapy)
Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups on the Quit Date
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.
Time frame: Quit date, visit 2 (one week after starting the 12-week course of therapy)
Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Medication Treatment (Visit 6)
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.
Time frame: Visit 6 (end of 12 weeks of medication therapy)
Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Pregnancy (Visit 7)
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.
Time frame: End of pregnancy (visit 7) is a time period between 36.0-38.6 weeks gestation
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.
| Milestone | Bupropion SR | Placebo |
|---|---|---|
| Started | 30 | 35 |
| Visit 2: quit day | 24 | 24 |
| Visit 6: end of treatment | 15 | 15 |
| Visit 7: 36-38 weeks gestation | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 20 | 25 |
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.
| MNWS Score | Bupropion SR | Placebo |
|---|---|---|
| Craving for tobacco | 1.50 ± 1.11 | 2.07 ± 1.23 |
| Total score of withdrawal excluding craving | 3.77 ± 4.27 | 5.35 ± 5.14 |
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.
| MNWS Score | Bupropion SR | Placebo |
|---|---|---|
| Craving for tobacco | 2.04 ± 1.08 | 2.33 ± 1.31 |
| Total score of withdrawal excluding craving | 4.75 ± 4.87 | 4.88 ± 4.61 |
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.
| Participants | Bupropion SR | Placebo |
|---|---|---|
| Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Medication Treatment (Visit 6) | 5 | 1 |
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.
| Participants | Bupropion SR | Placebo |
|---|---|---|
| Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Pregnancy (Visit 7) | 3 | 1 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bupropion SR | 0/30 (0%) | 2/30 (6.7%) | 14/30 (46.7%) |
| Placebo | 0/35 (0%) | 5/35 (14.3%) | 8/35 (22.9%) |
| Event | Bupropion SR | Placebo |
|---|---|---|
| Infant stay in NICU >3 days due to premature deliveryPregnancy, puerperium and perinatal conditions | 0/30 | 4/35 |
| PreeclampsiaPregnancy, puerperium and perinatal conditions | 1/30 | 0/35 |
| Cord blood pH <7.01Pregnancy, puerperium and perinatal conditions | 1/30 | 0/35 |
| Gestational DiabetesPregnancy, puerperium and perinatal conditions | 0/30 | 1/35 |
| Event | Bupropion SR | Placebo |
|---|---|---|
| AnxietyPsychiatric disorders | 14/30 | 6/35 |
| Dry mouthGastrointestinal disorders | 13/30 | 7/35 |
| HeadacheNervous system disorders | 12/30 | 6/35 |
| Difficulty sleepingNervous system disorders | 10/30 | 7/35 |
| Rhinorhea- Runny NoseRespiratory, thoracic and mediastinal disorders | 10/30 | 8/35 |
| Age, Categorical(Participants) | Bupropion SR | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 30 | 35 | 65 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Bupropion SR | Placebo | Total |
|---|---|---|---|
| Mean | 24.5 ± 5.56 | 27.5 ± 6.52 | 26.2 ± 6.2 |
| Sex: Female, Male(Participants) | Bupropion SR | Placebo | Total |
|---|---|---|---|
| Female | 30 | 35 | 65 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Bupropion SR | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 5 | 9 |
| Not Hispanic or Latino | 25 | 30 | 55 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Bupropion SR | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 13 | 16 |
| White | 27 | 22 | 49 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Bupropion SR | Placebo | Total |
|---|---|---|---|
| United States | 30 | 35 | 65 |
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The University of Texas Medical Branch, Galveston