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 whether starting bupropion, a smoking cessation medication, after a baby’s birth helps a postpartum woman to stop smoking.

Condition	Intervention	Phase
Tobacco Use Disorder	Drug: Bupropion SR	Phase IV

Further Study Details: 

Primary Outcomes: 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
Secondary Outcomes: 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
Expected Total Enrollment:  40

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): (1) Study eligibility, recruitment, and retention rates (primary outcome). (2) 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. (3) Postpartum weight loss and symptoms of depression and anxiety. (4) Tolerability of postpartum bupropion, assessed by medication adherence and adverse effects.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

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 Criteria:

• 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00119210

Nancy A Rigotti, MD      617-72474709    nrigotti@partners.org
Jennifer Haas, MD      617-525-6652    jhaas@partners.org

Massachusetts
      Brigham and Women''''s Hospital, Boston,  Massachusetts,  02115,  United States; Recruiting

Study chairs or principal investigators

Nancy A Rigotti, MD,  Principal Investigator,  Massachusetts General Hospital   

Study ID Numbers:  2004-P-001769; Grant #051794
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 12, 2005
ClinicalTrials.gov Identifier:  NCT00119210
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26