Overview

This trial is active, not recruiting.

Condition smoking cessation
Treatment bupropion sr
Phase phase 2
Sponsor The University of Texas Health Science Center, Houston
Collaborator M.D. Anderson Cancer Center
Start date April 2011
End date April 2014
Trial size 50 participants
Trial identifier NCT01286402, HSC-MS-09-0681

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Group receiving bupropion SR medication
bupropion sr Zyban, Wellbutrin
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 Comparator)
bupropion sr Zyban, Wellbutrin
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

Primary Outcomes

Measure
7-day point prevalence smoking abstinence with cotinine validation at the end of treatment
time frame: 1 week post treatment

Secondary Outcomes

Measure
Enrollment, retention and compliance rates
time frame: 1 year (estimated)
Continuous abstinence from end of treatment through the 2 week followup
time frame: at two week followup visit
Continuous abstinence from birth to 2nd week postpartum followup
time frame: at 2nd week postpartum followup visit
Self-reported reduction in number of cigarettes smoked per day
time frame: at 1 week post treatment and at 2 week postpartum visit
Maternal side effects
time frame: during treatment, end of treatment and at 2 week postpartum visit
Perinatal/neonatal outcomes
time frame: at neonatal discharge from hospital following delivery

Eligibility Criteria

Female participants at least 18 years old.

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)

Additional Information

Official title Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy
Principal investigator Angela L Stotts, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston.