Tobacco Use DisorderPhase 4NCT00119210
Pilot Study of Bupropion for Smoking Cessation in Postpartum Non-breastfeeding Women
A Phase 4 study testing Bupropion SR in people with Tobacco Use Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Bupropion SR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Mar 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 9Show fewer
- Newborn with major congenital anomaly or <25 weeks' gestation;
- Inability to speak or read English;
- No telephone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Bupropion for Smoking Cessation in Postpartum Women
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.
Read the 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.
- Conditions
- Tobacco Use Disorder
- Being tested
- Bupropion SR, placebo
- Keywords
- Tobacco use cessation, Bupropion, Zyban, Puerperium
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupropion SRDrug
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Sugar pill Receives: Other: placebo |
| Bupropion SR | Experimental | Not described Receives: Drug: Bupropion SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Adherence to study drug at 2 and 8 weeks postpartum
Rate of adverse effects at 2 and 8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2005 (estimated)
- Study startMar 2005
- Study completionMar 2006
Why it stopped: We were unable to recruit sufficient numbers of patients and decided that the study protocol was not feasible to implement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Investigators
- Nancy A Rigotti, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119210
- Sponsor's protocol ID
- 2004-P-001769
- Other IDs
- Grant #051794
- Status last verified
- Apr 2011
- First submitted
- 5 Jul 2005
- Last updated
- 29 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupropion for Smoking Cessation in Postpartum Women
- ClinicalTrials.gov ID
- NCT00119210
- Acronym / sponsor ID
- 2004-P-001769
- Conditions
- Tobacco Use Disorder
- Keywords
- Tobacco use cessation, Bupropion, Zyban, Puerperium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We were unable to recruit sufficient numbers of patients and decided that the study protocol was not feasible to implement
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Mar 2005
- Study completion
- Mar 2006 (actual)
- First posted
- 13 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: placeboSugar pill |
| Bupropion SR | Experimental | Drug: Bupropion SR |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupropion SR | Drug | Bupropion SR |
| placebo | Other | Placebo |
Primary outcome
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
7 secondary outcomes
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
Results and safety
The study was stopped early (reason given: We were unable to recruit sufficient numbers of patients and decided that the study protocol was not feasible to implement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy A Rigotti, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupropion SR in people with Tobacco Use Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: We were unable to recruit sufficient numbers of patients and decided that the study protocol was not feasible to implement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women who are eligible for the study. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2011.