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

Bupropion for Smoking Cessation in Postpartum Women

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.

Study Overview

• Status: Terminated
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Other: placebo; Drug: Bupropion SR

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Sugar pill	Other: placebo
Experimental: Bupropion SR	Drug: Bupropion SR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Robert Wood Johnson Foundation

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Study Completion (Actual): March 1, 2006

Study Registration Dates

• First Submitted: July 5, 2005
• First Submitted That Met QC Criteria: July 5, 2005
• First Posted (Estimate): July 13, 2005

Study Record Updates

• Last Update Posted (Estimate): April 29, 2011
• Last Update Submitted That Met QC Criteria: April 28, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Bupropion; Zyban; Tobacco use cessation; Puerperium
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: 2004-P-001769; Grant #051794