Clinical trial NCT00119210: Pilot Study of Bupropion for Smoking Cessation in Postpartum Non-breastfeeding Women
Official title: Bupropion for Smoking Cessation in Postpartum Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Tobacco Use Disorder
Keywords: Tobacco use cessation
Bupropion
Zyban
Puerperium
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2005-07-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Proportion of women who are eligible for the study
measure: Proportion of eligible women who enroll in the study
measure: Proportion of enrolled women who complete the study
Secondary outcomes:
measure: Cotinine-verified 7-day tobacco abstinence at 2 weeks
measure: Cotinine-verified 7-day tobacco abstinence at 8 weeks
measure: Cotinine-verified 7-day tobacco abstinence at 12 weeks
measure: Symptoms of depression at 2, 8, and 12 weeks postpartum
measure: Symptoms of anxiety at 2, 8, and 12 weeks postpartum
measure: Adherence to study drug at 2 and 8 weeks postpartum
measure: Rate of adverse effects at 2 and 8 weeks postpartum
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Nancy A Rigotti, MD
role: PRINCIPAL_INVESTIGATOR
References: