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

History of Changes

Purpose

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	Intervention	Phase
Tobacco Use Disorder	Drug: Bupropion SR Other: placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Bupropion for Smoking Cessation in Postpartum Women

Resource links provided by NLM:

MedlinePlus related topics: Postpartum Care Quitting Smoking Smoking

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

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:

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


Estimated Enrollment:	40
Study Start Date:	March 2005
Study Completion Date:	March 2006

Arms	Assigned Interventions
Placebo Comparator: Placebo Sugar pill	Other: placebo
Experimental: Bupropion SR	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):

Study eligibility, recruitment, and retention rates (primary outcome).
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.
Postpartum weight loss and symptoms of depression and anxiety.
Tolerability of postpartum bupropion, assessed by medication adherence and adverse effects.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Nancy Rigotti, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00119210 History of Changes
Other Study ID Numbers:	2004-P-001769 Grant #051794
Study First Received:	July 5, 2005
Last Updated:	April 28, 2011
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 30, 2016

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