Bupropion for Smoking Cessation in Pregnancy
Condition: Smoking Cessation; Pregnancy
Study type: Interventional
Phase: Phase 2

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

Detailed description: 
      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:

        1. 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.

        2. 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.

        3. 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.

        4. 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.
    

Intervention name(s): Bupropion SR; placebo; smoking cessation counseling
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Comparison of bupropion SR or placebo + smoking cessation counseling
Other intervention name(s): Wellbutrin SR; Zyban SR
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bupropion SR; randomized controlled trial; pregnancy