Tobacco Use Disorder
Conditions
Keywords
Tobacco use cessation, Bupropion, Zyban, Puerperium
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.
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.
Interventions
DRUGBupropion SR
OTHERplacebo
Sponsors
Robert Wood Johnson Foundation
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed