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

NCT ID: NCT01286402

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-05-31

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bupropion SR (sustained release)

Group receiving bupropion SR medication

Group Type: EXPERIMENTAL

Bupropion SR

Intervention Type: 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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: OTHER

Other Intervention Names

Zyban, Wellbutrin

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
• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: collaborator

Gilstrap, Larry C, M.D.

INDIV

Sponsor Role: collaborator

The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Angela Stotts

Associate Professor - Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela L Stotts, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

University of Texas Health Science Center at Houston, Professional Building

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-09-0681

Identifier Type: -

Identifier Source: org_study_id