Bupropion 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.

Inclusion Criteria:

- smoking at least 10 CPD prior to pregnancy and 5 CPD for the preceding 7 days

- 13-30 weeks gestation

- ≥18 years of age

- able to speak English or Spanish

- intent to carry pregnancy to term

- stable residence

Exclusion Criteria:

- current illicit drug or alcohol abuse or dependence

- twins or other multiple gestation

- treatment for psychiatric disorder within the last 6 months

- unstable medical problems (eg, hypertension (BP>140/90), preeclampsia, threatened
abortion, hyperemesis gravidarum)

- known congenital abnormality

- seizure disorder

- use of psychotropic medication

- use of medication known to lower the seizure threshold

- anorexia/bulimia

- a personal history of closed head trauma with > 30 minutes of loss of consciousness or
amnesia or resulting in skull fracture or subdural hematoma/brain contusion

- use of any other smoking cessation treatment in the past 30 days

- current enrollment in methadone treatment program

- prior pregnancy with preeclampsia diagnosis

- chronic hypertension (past history or current diagnosis)