Pilot Study of Bupropion for Smoking Cessation in Postpartum Non-breastfeeding Women
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|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|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|