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

Phase 2

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
Bupropion SR (sustained release)	Bupropion SR	Group receiving bupropion SR medication
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment	1 week post treatment

Secondary Outcome Measures

Name	Time	Method
Enrollment, Retention and Compliance Rates	1 year (estimated)
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
Continuous Abstinence From End of Treatment Through the 2 Week Followup	at two week followup visit