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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Bupropion SR; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; -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
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 Names: Zyban, Wellbutrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment	1 week post treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Enrollment, Retention and Compliance Rates	1 year (estimated)
Continuous Abstinence From End of Treatment Through the 2 Week Followup	at two week followup visit
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: 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; Gilstrap, Larry C, M.D.
• Investigators: Principal Investigator: Angela L Stotts, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: January 25, 2011
• First Submitted That Met QC Criteria: January 27, 2011
• First Posted (Estimate): January 31, 2011

Study Record Updates

• Last Update Posted (Estimate): February 4, 2016
• Last Update Submitted That Met QC Criteria: January 5, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: bupropion; Smoking cessation during pregnancy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: HSC-MS-09-0681