Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Bupropion SR
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women ≥ 18 years of age Gestational age between 14 and 26 weeks confirmed by ultrasound Currently smoking ≥ 5 cigarettes per day Exclusion Criteria: Abnormal liver function tests History of or current seizure disorder or closed head injury with loss of consciousness Known hypersensitivity to bupropion Any psychiatric disorder requiring psychotropic medication Current anorexia or bulimia Use of monoamine oxidase (MAO) inhibitors or discontinuation within the past 2 weeks Major Depressive Disorder or current suicidal risk Use of any illicit substances since receiving knowledge of pregnancy Regular use of alcohol (>1 drink/week on average) Unstable medical problems, such as liver or renal disease, uncontrollable hypertension, and lupus Twins or other multiple gestation Fetal abnormality on the 14 week ultrasound Plans to deliver at a hospital other than Memorial Hermann Inability to communicate with research staff or make study visits due to lack of phone or transportation access Participation in another clinical study which may affect study outcomes Current use of any Nicotine Replacement Therapy (NRT), bupropion, or varenicline (Chantix)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupropion SR (sustained release)<br>Group receiving bupropion SR medication | Drug: Bupropion SR<br>* 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<br>* Other names: Zyban, Wellbutrin;|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* -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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment |  | 1 week post treatment | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation during pregnancy, bupropion