NCT00119210

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 13, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

April 29, 2011

Status Verified

April 1, 2011

First QC Date

July 5, 2005

Last Update Submit

April 28, 2011

Conditions

Tobacco Use Disorder

Keywords

Tobacco use cessationBupropionZybanPuerperium

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Sugar pill

Other: placebo

Bupropion SR

EXPERIMENTAL
Drug: Bupropion SR

Interventions

Bupropion SRDRUG
Bupropion SR
placeboOTHER
Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderTobacco Use Cessation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Study Officials

  • Nancy A Rigotti, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2005

First Posted

July 13, 2005

Study Start

March 1, 2005

Study Completion

March 1, 2006

Last Updated

April 29, 2011

Record last verified: 2011-04

Locations

US(1)