Status:
TERMINATED
Pilot Study of Bupropion for Smoking Cessation in Postpartum Non-breastfeeding Women
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Robert Wood Johnson Foundation
Conditions:
Tobacco Use Disorder
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this small preliminary study is to determine whether it is feasible to recruit women smokers who have just delivered a baby and are not breastfeeding into a study that would test whethe...
Detailed Description
Purpose: A pilot randomized double-blind placebo-controlled trial is testing the feasibility of conducting a full-scale trial of the efficacy of bupropion SR vs. placebo in non-breastfeeding postpartu...
Eligibility Criteria
Inclusion
- Postpartum women who:
- Smoked \>1 cigarette in last month of pregnancy
- Deliver a baby at Brigham and Women's Hospital in Boston, MA
- Do not breastfeed or plan to breastfeed.
- Want to attempt to stop smoking
Exclusion
- Age \<18 years;
- Current use of bupropion or antidepressant;
- Current major depression or other severe psychiatric illness (e.g., schizophrenia, mania);
- Contraindication to use of bupropion;
- Illegal substance use in past 6 months;
- \>1 drink/day of alcohol during pregnancy;
- Newborn with major congenital anomaly or \<25 weeks' gestation;
- Inability to speak or read English;
- No telephone.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00119210
Start Date
March 1 2005
End Date
March 1 2006
Last Update
April 29 2011
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115