NCT01390246

Bupropion for Smoking Cessation During Pregnancy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pregnancy Related
• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	Bupropion SR	Bupropion SR 150 mg tablet
BEHAVIORAL	Smoking Cessation Counseling	35-min counseling by trained research nurse
DRUG	Placebo	Matching Bupropion SR placebo tablet

Timeline

• Start date: 2011-07-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2011-07-08
• Last updated: 2019-06-07
• Results posted: 2018-02-13

Locations

1 site across 1 country: United States