Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy
18 Years
N/A
Female
Smoking Cessation
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
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)
Type of Study:
Interventional
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:
No
Principal Investigator
Angela L Stotts, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The University of Texas Health Science Center, Houston
Authority:
United States: Food and Drug Administration
Study ID:
HSC-MS-09-0681
NCT ID:
NCT01286402
Start Date:
April 2011
Completion Date:
April 2014
Related Keywords:
- Smoking Cessation
- Smoking cessation during pregnancy
- bupropion
- Smoking
Name | Location |
|---|---|
| University of Texas Health Science Center at Houston, Professional Building | Houston, Texas 77030 |
