Pilot Study of Bupropion for Smoking Cessation in Postpartum Non-breastfeeding Women
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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 |
- 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
- 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 |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00119210
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Nancy A Rigotti, MD | Massachusetts General Hospital |
More Information
No publications provided
| 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 Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Bupropion Antidepressive Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Dopamine Agents |
Dopamine Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015