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Completed

NCT Number: NCT01286402

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

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Texas Health Science Center at Houston, Professional Building

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bupropion SR

Drug
  • 150mg, taken orally, taken daily for the 1st 3 days
  • 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment

Other names: Zyban, Wellbutrin

Placebo

Other

-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment

Primary outcomes

  1. 7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment

    Time frame: 1 week post treatment

Secondary outcomes

  1. Enrollment, Retention and Compliance Rates

    Time frame: 1 year (estimated)

  2. Continuous Abstinence From End of Treatment Through the 2 Week Followup

    Time frame: at two week followup visit

  3. Continuous Abstinence From Birth to 2nd Week Postpartum Followup

    Time frame: at 2nd week postpartum followup visit

  4. Self-reported Reduction in Number of Cigarettes Smoked Per Day

    Time frame: at 1 week post treatment and at 2 week postpartum visit

  5. Maternal Side Effects

    Time frame: during treatment, end of treatment and at 2 week postpartum visit

  6. Perinatal/Neonatal Outcomes

    Time frame: at neonatal discharge from hospital following delivery

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Gilstrap, Larry C, M.D.
  • M.D. Anderson Cancer Center
  • The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jan 31, 2011
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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