Pilot Study of Bupropion for Smoking Cessation in Postpartum Non-breastfeeding Women

NCT ID: NCT00119210

Last Updated: 2011-04-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2006-03-31

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

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 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.

Conditions

Tobacco Use Disorder

Keywords

Tobacco use cessation; Bupropion; Zyban; Puerperium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Sugar pill

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Bupropion SR

Group Type: EXPERIMENTAL

Bupropion SR

Intervention Type: DRUG

Interventions

Bupropion SR

Intervention Type: DRUG

placebo

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Robert Wood Johnson Foundation

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Massachusetts General Hospital

Principal Investigators

Nancy A Rigotti, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

Grant #051794

Identifier Type: -

Identifier Source: secondary_id

2004-P-001769

Identifier Type: -

Identifier Source: org_study_id