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

Tobacco Use Disorder Clinical Trial

Official title:

Bupropion for Smoking Cessation in Postpartum Women

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00119210
• Other study ID #: 2004-P-001769
• Secondary ID: Grant #051794
• Status: Terminated
• Phase: Phase 4
• First received: July 5, 2005
• Last updated: April 28, 2011
• Start date: March 2005
• Est. completion date: March 2006

Study information

• Verified date: April 2011
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• Bupropion SR

Other:
• placebo

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women who are eligible for the study
Primary	Proportion of eligible women who enroll in the study
Primary	Proportion of enrolled women who complete the study
Secondary	Cotinine-verified 7-day tobacco abstinence at 2 weeks
Secondary	Cotinine-verified 7-day tobacco abstinence at 8 weeks
Secondary	Cotinine-verified 7-day tobacco abstinence at 12 weeks
Secondary	Symptoms of depression at 2, 8, and 12 weeks postpartum
Secondary	Symptoms of anxiety at 2, 8, and 12 weeks postpartum
Secondary	Adherence to study drug at 2 and 8 weeks postpartum
Secondary	Rate of adverse effects at 2 and 8 weeks postpartum