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

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ClinicalTrials.gov Identifier: NCT00119210
Recruitment Status : Terminated (We were unable to recruit sufficient numbers of patients and decided that the study protocol was not feasible to implement)
First Posted : July 13, 2005
Last Update Posted : April 29, 2011
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by:
Massachusetts General Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Bupropion SR Other: placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bupropion for Smoking Cessation in Postpartum Women
Study Start Date : March 2005
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Sugar pill
 Other: placebo
Experimental: Bupropion SR Drug: Bupropion SR


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of women who are eligible for the study
  2. Proportion of eligible women who enroll in the study
  3. Proportion of enrolled women who complete the study

Secondary Outcome Measures :
  1. Cotinine-verified 7-day tobacco abstinence at 2 weeks
  2. Cotinine-verified 7-day tobacco abstinence at 8 weeks
  3. Cotinine-verified 7-day tobacco abstinence at 12 weeks
  4. Symptoms of depression at 2, 8, and 12 weeks postpartum
  5. Symptoms of anxiety at 2, 8, and 12 weeks postpartum
  6. Adherence to study drug at 2 and 8 weeks postpartum
  7. Rate of adverse effects at 2 and 8 weeks postpartum

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119210


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Nancy A Rigotti, MD Massachusetts General Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Nancy Rigotti, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00119210     History of Changes
Other Study ID Numbers: 2004-P-001769
Grant #051794
First Posted: July 13, 2005    Key Record Dates
Last Update Posted: April 29, 2011
Last Verified: April 2011

Keywords provided by Massachusetts General Hospital:
Tobacco use cessation
Bupropion
Zyban
Puerperium

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors