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

This study has been terminated.
(We were unable to recruit sufficient numbers of patients and decided that the study protocol was not feasible to implement)
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00119210
First received: July 5, 2005
Last updated: April 28, 2011
Last verified: April 2011

July 5, 2005
April 28, 2011
March 2005
Not Provided
  • 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
Same as current
Complete list of historical versions of study NCT00119210 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Tobacco Use Disorder
  • Drug: Bupropion SR
  • Other: placebo
  • Placebo Comparator: Placebo
    Sugar pill
    Intervention: Other: placebo
  • Experimental: Bupropion SR
    Intervention: Drug: Bupropion SR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
March 2006
Not Provided

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00119210
2004-P-001769, Grant #051794
Not Provided
Nancy Rigotti, MD, Massachusetts General Hospital
Massachusetts General Hospital
Robert Wood Johnson Foundation
Principal Investigator: Nancy A Rigotti, MD Massachusetts General Hospital
Massachusetts General Hospital
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP