Pilot Study of Bupropion for Smoking Cessation in Postpartum Non-breastfeeding Women
|ClinicalTrials.gov Identifier: NCT00119210|
Recruitment Status : Terminated (We were unable to recruit sufficient numbers of patients and decided that the study protocol was not feasible to implement)
First Posted : July 13, 2005
Last Update Posted : April 29, 2011
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Disorder||Drug: Bupropion SR Other: placebo||Phase 4|
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 postpartum women who smoked >1 cigarette in the last month of pregnancy and want to stop smoking. The study will estimate achievable enrollment and retention rates; estimate the effect size of the drug on tobacco abstinence; assess the tolerability of bupropion in postpartum women; and allow refinement of recruitment, retention, intervention, and assessment protocols.
Research Design: Pilot double-blind placebo-controlled randomized clinical trial.
Study Population: 40 postpartum women aged 18 years or older who smoked > 1 cigarette in the last month of pregnancy, want to stop smoking, and are not breastfeeding. Subjects will be recruited postpartum while hospitalized after delivery.
Intervention: Bupropion SR (or matching placebo) for 8 weeks, starting immediately post-delivery. The dose is 150 mg qd for one week then 150 mg bid for 7 weeks. All subjects will receive behavioral counseling delivered face-to-face during the post-delivery hospitalization and by telephone 4 times over 8 weeks.
Outcome Measures: (assessed at 2, 4, 8, and 12 weeks postpartum):
- Study eligibility, recruitment, and retention rates (primary outcome).
- Tobacco abstinence (7-day point prevalence nonsmoking by self-report and confirmed by saliva cotinine at 2 weeks, 8 weeks (end of drug treatment), and 12 weeks postpartum.
- Postpartum weight loss and symptoms of depression and anxiety.
- Tolerability of postpartum bupropion, assessed by medication adherence and adverse effects.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Bupropion for Smoking Cessation in Postpartum Women|
|Study Start Date :||March 2005|
|Actual Study Completion Date :||March 2006|
Placebo Comparator: Placebo
|Experimental: Bupropion SR||Drug: Bupropion SR|
- Proportion of women who are eligible for the study
- Proportion of eligible women who enroll in the study
- Proportion of enrolled women who complete the study
- Cotinine-verified 7-day tobacco abstinence at 2 weeks
- Cotinine-verified 7-day tobacco abstinence at 8 weeks
- Cotinine-verified 7-day tobacco abstinence at 12 weeks
- Symptoms of depression at 2, 8, and 12 weeks postpartum
- Symptoms of anxiety at 2, 8, and 12 weeks postpartum
- Adherence to study drug at 2 and 8 weeks postpartum
- Rate of adverse effects at 2 and 8 weeks postpartum
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119210
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Nancy A Rigotti, MD||Massachusetts General Hospital|