Bupropion for Smoking Cessation During Pregnancy

Pregnancy Related Clinical Trial

Official title: Bupropion for Smoking Cessation During Pregnancy

Status Completed

Clinical Trial Summary

This is a prospective, double-blind placebo-controlled randomized pilot trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy.

Clinical Trial Description

This is a prospective, double-blind placebo-controlled randomized pilot trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy. A total of 150 pregnant smokers will receive medication (75) or placebo (75) for 12 weeks. Compassionate care/continuance of therapy will be available to pregnant subjects. Women who relapse to smoking postpartum will be offered an additional course of medication treatment. All subjects regardless of adherence with 12 week study drug administration period and smoking habits during pregnancy will be followed through the duration of their pregnancy, delivery, and 6-month postpartum period. Subject participation will begin between 13-30 wks of gestation and end 6 months postpartum. Participation will be ten (10) to thirteen(13) months in length. ;

Related Conditions & MeSH terms

• Pregnancy Related
• Tobacco Use Disorder

• NCT number: NCT01390246
• Study type: Interventional
• Source: The University of Texas Medical Branch, Galveston
• Status: Completed
• Phase: Phase 4
• Start date: July 2011
• Completion date: December 2016