Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy
Overview
- Phase
- Phase 2
- Intervention
- Bupropion SR
- Conditions
- Smoking Cessation
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- 7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Angela Stotts
Associate Professor - Family Medicine
The University of Texas Health Science Center, Houston
Eligibility Criteria
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
Arms & Interventions
Bupropion SR (sustained release)
Group receiving bupropion SR medication
Intervention: Bupropion SR
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment
Time Frame: 1 week post treatment
Secondary Outcomes
- 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)