Bupropion for Smoking Cessation in Pregnancy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether bupropion SR increases cessation and/or smoking reduction among pregnant smokers.

Detailed Description
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Primary Objective: To evaluate the efficacy of a pharmacologic agent (bupropion SR) to achieve higher rates of smoking cessation and greater reduction in smoking during pregnancy Secondary Objective: To evaluate the safety of using a pharmacologic agent (bupropion SR) for smoking cessation in pregnancy. Hypotheses to be tested: Bupropion SR combined with smoking cessation counseling during pregnancy will increase smoking cessation, compared to smoking cessation counseling combined with placebo, or standard of care. Bupropion SR combined with smoking cessation counseling during pregnancy will produce greater reduction in smoking in patients unable to quit, as compared to smoking cessation counseling combined with placebo, or standard of care. Bupropion SR combined with smoking cessation counseling during pregnancy will improve perinatal outcomes (by decreasing preterm birth, preterm premature rupture of membranes, antenatal bleeding, low birth weight, intrauterine growth restriction and increasing maternal weight gain), as compared to smoking cessation counseling combined with placebo, or standard of care. Bupropion SR combined with smoking cessation counseling during pregnancy will increase the rate of smoking cessation without increasing the number of adverse events reported by women, as compared to smoking cessation counseling combined with placebo, or standard of care. Few studies have offered pregnant women pharmacologic assistance with their tobacco addiction for the purpose of achieving smoking cessation in pregnancy. In view of the evidence from the non-pregnant population, pharmacologic assistance with either nicotine replacement therapy or bupropion is essential to significant cessation and reduction programs. This pilot study is designed to generate sufficient preliminary data to support future grant applications to state and/or federal funding agencies for adequate funding to conduct a properly powered randomized clinical trial. This pilot study will provide useful information for future sample size calculations and give some indication as to the rate of adverse reactions and safety profile of bupropion taken during pregnancy. Cigarette smoking is associated with various complications of pregnancy., Likewise, infants and children of women who smoke during pregnancy are at greater risk for a myriad of physical and developmental problems. Women who participate in the study and receive the intervention may benefit if they reduce or stop their tobacco use. Decreased cigarette smoking by pregnant subjects enrolled in this study may lead to a reduction in complications of pregnancy and health problems of infants and children that are attributable to smoking. The standard therapy for pregnant women is to receive some directive counseling from their clinician. Occasionally, patients will even be referred to community organizations to reinforce the office counseling. The evidence suggests that there is limited value to behavioral counseling alone and that most clinicians are not properly trained and that those who are, do not have the time to adequately counsel patients. There are no smoking cessation programs currently available in the Tucson community that offer pharmacologic assistance in combination with counseling to pregnant women. Individual clinicians do prescribe pharmacologic aids for their patients on a case by case basis. Smoking cessation counseling is evidence based. However, as the investigators have previously indicated it is rarely conveyed to patients because of inadequate training and time. There is currently no support within obstetrical healthcare funding to subsidize the cost of this service.

Official Title
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Smoking Cessation in Pregnancy: A Pilot Study Comparing Counseling With and Without Sustained-Release Bupropion

Conditions
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Smoking Cessation, Pregnancy

Intervention / Treatment
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* Drug: Bupropion SR
* Drug: placebo
* Behavioral: smoking cessation counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smoked at least one puff in the past 7 days Confirmed viable gestation Exclusion Criteria: All patients found to have a non-viable fetus or major congenital anomaly History of seizure disorder Family history of seizure disorder History of severe head trauma History of anorexia nervosa or bulimia Current use of nicotine-replacement therapy Unstable medical or psychiatric condition Current use of an monoamine oxidase inhibitor or bupropion hydrochloride products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupropion SR<br>Study medication (150 mg bupropion SR) daily for 14 days. Women still smoking at 2-weeks & 4-weeks were encouraged to increase their medication to two times per day (150 mg bid). Women received smoking cessation counseling at baseline, 2, 4, 6, and 8 weeks. | Drug: Bupropion SR<br>* Comparison of bupropion SR or placebo + smoking cessation counseling<br>* Other names: Zyban SR;Behavioral: smoking cessation counseling<br> <br> |
| Placebo Comparator: Placebo<br>Study medication (placebo) daily for 14 days. Women still smoking at 2-weeks & 4-weeks were encouraged to increase their medication to two times per day. Women received smoking cessation counseling at baseline, 2, 4, 6, and 8 weeks. | Drug: placebo<br> <br> Behavioral: smoking cessation counseling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biologically verified smoking cessation or reduction | change in smoking from study enrollment to end of treatment (8 weeks) and at delivery | 8 weeks and delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events reported during pregnancy |  | 8 weeks and delivery | 
| self reported smoking cessation or reduction | change in self reported smoking from study enrollment to end of treatment (8 weeks) and at delivery | 8 weeks and delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bupropion SR, randomized controlled trial, pregnancy