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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Gilstrap, Larry C, M.D.
The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
Information provided by (Responsible Party):
Angela Stotts, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01286402
First received: January 25, 2011
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Drug: Bupropion SR
Phase 2

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

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 7-day point prevalence smoking abstinence with cotinine validation at the end of treatment [ Time Frame: 1 week post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Enrollment, retention and compliance rates [ Time Frame: 1 year (estimated) ] [ Designated as safety issue: No ]
  • Continuous abstinence from end of treatment through the 2 week followup [ Time Frame: at two week followup visit ] [ Designated as safety issue: No ]
  • Continuous abstinence from birth to 2nd week postpartum followup [ Time Frame: at 2nd week postpartum followup visit ] [ Designated as safety issue: No ]
  • Self-reported reduction in number of cigarettes smoked per day [ Time Frame: at 1 week post treatment and at 2 week postpartum visit ] [ Designated as safety issue: No ]
  • Maternal side effects [ Time Frame: during treatment, end of treatment and at 2 week postpartum visit ] [ Designated as safety issue: Yes ]
  • Perinatal/neonatal outcomes [ Time Frame: at neonatal discharge from hospital following delivery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: April 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bupropion SR (sustained release)
Group receiving bupropion SR medication
Drug: Bupropion SR
  • 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 Name: Zyban, Wellbutrin
Placebo Comparator: Placebo Drug: Bupropion SR
  • 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 Name: Zyban, Wellbutrin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286402

Locations
United States, Texas
University of Texas Health Science Center at Houston, Professional Building
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
M.D. Anderson Cancer Center
Gilstrap, Larry C, M.D.
The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
Investigators
Principal Investigator: Angela L Stotts, PhD The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Angela Stotts, Associate Professor - Family Medicine, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01286402     History of Changes
Other Study ID Numbers: HSC-MS-09-0681
Study First Received: January 25, 2011
Last Updated: June 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:
Smoking cessation during pregnancy
bupropion

Additional relevant MeSH terms:
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2014