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

Phase 2
18 Years
Open (Enrolling)
Smoking Cessation

Thank you

Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

7-day point prevalence smoking abstinence with cotinine validation at the end of treatment

Outcome Time Frame:

1 week post treatment

Safety Issue:


Principal Investigator

Angela L Stotts, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas Health Science Center, Houston


United States: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

April 2014

Related Keywords:

  • Smoking Cessation
  • Smoking cessation during pregnancy
  • bupropion
  • Smoking



University of Texas Health Science Center at Houston, Professional Building Houston, Texas  77030