Bupropion for Smoking Cessation in Pregnancy

June 10, 2013 updated by: Hugh Miller, Watching Over Mothers & Babies Foundation

Smoking Cessation in Pregnancy: A Pilot Study Comparing Counseling With and Without Sustained-Release Bupropion

The purpose of this study is to determine whether bupropion SR increases cessation and/or smoking reduction among pregnant smokers.

Study Overview

Detailed Description

Primary Objective:

To evaluate the efficacy of a pharmacologic agent (bupropion SR) to achieve higher rates of smoking cessation and greater reduction in smoking during pregnancy

Secondary Objective:

To evaluate the safety of using a pharmacologic agent (bupropion SR) for smoking cessation in pregnancy.

Hypotheses to be tested:

  1. Bupropion SR combined with smoking cessation counseling during pregnancy will increase smoking cessation, compared to smoking cessation counseling combined with placebo, or standard of care.
  2. Bupropion SR combined with smoking cessation counseling during pregnancy will produce greater reduction in smoking in patients unable to quit, as compared to smoking cessation counseling combined with placebo, or standard of care.
  3. Bupropion SR combined with smoking cessation counseling during pregnancy will improve perinatal outcomes (by decreasing preterm birth, preterm premature rupture of membranes, antenatal bleeding, low birth weight, intrauterine growth restriction and increasing maternal weight gain), as compared to smoking cessation counseling combined with placebo, or standard of care.
  4. Bupropion SR combined with smoking cessation counseling during pregnancy will increase the rate of smoking cessation without increasing the number of adverse events reported by women, as compared to smoking cessation counseling combined with placebo, or standard of care.

Few studies have offered pregnant women pharmacologic assistance with their tobacco addiction for the purpose of achieving smoking cessation in pregnancy. In view of the evidence from the non-pregnant population, pharmacologic assistance with either nicotine replacement therapy or bupropion is essential to significant cessation and reduction programs. This pilot study is designed to generate sufficient preliminary data to support future grant applications to state and/or federal funding agencies for adequate funding to conduct a properly powered randomized clinical trial. This pilot study will provide useful information for future sample size calculations and give some indication as to the rate of adverse reactions and safety profile of bupropion taken during pregnancy.

Cigarette smoking is associated with various complications of pregnancy., Likewise, infants and children of women who smoke during pregnancy are at greater risk for a myriad of physical and developmental problems. Women who participate in the study and receive the intervention may benefit if they reduce or stop their tobacco use. Decreased cigarette smoking by pregnant subjects enrolled in this study may lead to a reduction in complications of pregnancy and health problems of infants and children that are attributable to smoking.

The standard therapy for pregnant women is to receive some directive counseling from their clinician. Occasionally, patients will even be referred to community organizations to reinforce the office counseling. The evidence suggests that there is limited value to behavioral counseling alone and that most clinicians are not properly trained and that those who are, do not have the time to adequately counsel patients. There are no smoking cessation programs currently available in the Tucson community that offer pharmacologic assistance in combination with counseling to pregnant women. Individual clinicians do prescribe pharmacologic aids for their patients on a case by case basis.

Smoking cessation counseling is evidence based. However, as the investigators have previously indicated it is rarely conveyed to patients because of inadequate training and time. There is currently no support within obstetrical healthcare funding to subsidize the cost of this service.

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Tucson, Arizona, United States, 85712
        • Watching Over Mothers and Babies Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Smoked at least one puff in the past 7 days
  • Confirmed viable gestation

Exclusion Criteria:

  • All patients found to have a non-viable fetus or major congenital anomaly
  • History of seizure disorder
  • Family history of seizure disorder
  • History of severe head trauma
  • History of anorexia nervosa or bulimia
  • Current use of nicotine-replacement therapy
  • Unstable medical or psychiatric condition
  • Current use of an monoamine oxidase inhibitor or bupropion hydrochloride products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bupropion SR
Study medication (150 mg bupropion SR) daily for 14 days. Women still smoking at 2-weeks & 4-weeks were encouraged to increase their medication to two times per day (150 mg bid). Women received smoking cessation counseling at baseline, 2, 4, 6, and 8 weeks.
Comparison of bupropion SR or placebo + smoking cessation counseling
Other Names:
  • Wellbutrin SR
  • Zyban SR
PLACEBO_COMPARATOR: Placebo
Study medication (placebo) daily for 14 days. Women still smoking at 2-weeks & 4-weeks were encouraged to increase their medication to two times per day. Women received smoking cessation counseling at baseline, 2, 4, 6, and 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biologically verified smoking cessation or reduction
Time Frame: 8 weeks and delivery
change in smoking from study enrollment to end of treatment (8 weeks) and at delivery
8 weeks and delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events reported during pregnancy
Time Frame: 8 weeks and delivery
8 weeks and delivery
self reported smoking cessation or reduction
Time Frame: 8 weeks and delivery
change in self reported smoking from study enrollment to end of treatment (8 weeks) and at delivery
8 weeks and delivery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
depression
Time Frame: 8 weeks and delivery
change in depression (measured by the Edinburgh postnatal depression scale) between study enrollment and end of treatment (8 weeks)
8 weeks and delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Hugh S Miller, MD, Watching Over Mothers and Babies Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (ACTUAL)

January 1, 2004

Study Completion (ACTUAL)

January 1, 2004

Study Registration Dates

First Submitted

April 14, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (ESTIMATE)

June 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 11, 2013

Last Update Submitted That Met QC Criteria

June 10, 2013

Last Verified

June 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking Cessation

Clinical Trials on placebo

3
Subscribe