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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
| Gilstrap, Larry C, M.D. | INDIV |
| The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston |
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This study is designed to gather preliminary effectiveness and safety data on the use of bupropion for smoking cessation in pregnant women attending a community prenatal clinic. This study will provide critical preliminary data in preparation for a larger, Phase III clinical trial.
A randomized, double-blind, parallel group design will be used to allow a rigorous preliminary assessment of the feasibility, effectiveness, and safety of bupropion SR (sustained release; packaged as Zyban by GlaxoSmithKline) in promoting smoking cessation among women in their second and third trimester of pregnancy. Fifty pregnant smokers will be randomized to receive an 8-week course of either bupropion SR or matching placebo tablets. Both groups will receive evidence-based smoking cessation counseling. The primary smoking outcome will be 7-day point prevalence abstinence with cotinine validation at the end of the treatment. Secondary outcomes include enrollment, retention, and compliance rates; continuous abstinence from end of treatment through the 2 week followup; continuous abstinence from birth to 2nd week postpartum followup; self-reported reduction in number of cigarettes smoked per day; and maternal side effects and perinatal/neonatal outcomes. Preliminary smoking cessation and safety outcomes will be assessed for the generation of evidence-based hypotheses regarding clinical benefit of bupropion for pregnant smokers in preparation fo a larger trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupropion SR (sustained release) | Experimental | Group receiving bupropion SR medication |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupropion SR | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment | 1 week post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment, Retention and Compliance Rates | 1 year (estimated) | |
| Continuous Abstinence From End of Treatment Through the 2 Week Followup | at two week followup visit | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela L Stotts, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at Houston, Professional Building | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupropion SR (Sustained Release) | Group receiving bupropion SR medication Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days - 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment |
| FG001 | Placebo | Group receiving placebo -Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupropion SR (Sustained Release) | Group receiving bupropion SR medication Bupropion SR: - 150mg, taken orally, taken daily for the 1st 3 days - 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment | Posted | Number | participants | 1 week post treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bupropion SR (Sustained Release) | Group receiving bupropion SR medication Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days - 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Newborn readmission for respiratory failure on day of life 5 | Respiratory, thoracic and mediastinal disorders | MOTHER HAD UPPER RESPIRATORY SYMPTOMS SUGGESTIVE OF INFECTION. INFANT HAD DECREASED FEEDING, LETHARY, DEHYDRATION AND DEVELOPED APNOEA AND WAS INTUBATED FOR RESPIRATORY SUPPORT. EVENT THOUGHT NOT BE RELATED TO STUDY MEDICATION AND IS RESOLVED. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Stotts, PhD, PI | University of Texas Health Science Center at Houston | 713-500-7590 | Angela.L.Stotts@uth.tmc.edu |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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|
| Placebo | Other | -Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment |
|
| Continuous Abstinence From Birth to 2nd Week Postpartum Followup |
| at 2nd week postpartum followup visit |
| Self-reported Reduction in Number of Cigarettes Smoked Per Day | at 1 week post treatment and at 2 week postpartum visit |
| Maternal Side Effects | during treatment, end of treatment and at 2 week postpartum visit |
| Perinatal/Neonatal Outcomes | at neonatal discharge from hospital following delivery |
Group receiving placebo -Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| # cigs smoked in past 30 days | Mean | Standard Deviation | cigarettes |
|
| Age started smoking | Mean | Standard Deviation | years |
|
| Carbon monoxide reading | Mean | Standard Deviation | parts per million |
|
|
|
| Secondary | Enrollment, Retention and Compliance Rates | Not Posted | 1 year (estimated) |
| Secondary | Continuous Abstinence From End of Treatment Through the 2 Week Followup | Not Posted | at two week followup visit |
| Secondary | Continuous Abstinence From Birth to 2nd Week Postpartum Followup | Not Posted | at 2nd week postpartum followup visit |
| Secondary | Self-reported Reduction in Number of Cigarettes Smoked Per Day | Not Posted | at 1 week post treatment and at 2 week postpartum visit |
| Secondary | Maternal Side Effects | Not Posted | during treatment, end of treatment and at 2 week postpartum visit |
| Secondary | Perinatal/Neonatal Outcomes | Not Posted | at neonatal discharge from hospital following delivery |
| 2 |
| 5 |
| 2 |
| 5 |
| EG001 | Placebo | Group receiving placebo -Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment | 0 | 6 | 3 | 6 |
|
| Hyperbilirubinemia secondary to ABO incompatibility | Hepatobiliary disorders |
|
| Dry mouth | General disorders |
|
| Agitation | Nervous system disorders |
|
| nausea | Gastrointestinal disorders |
|
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