Bupropion for Smoking Cessation in Pregnancy

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875172
• Other study ID #: 1R21CA089510-01A2
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2013
• Last updated: June 10, 2013
• Start date: October 2001
• Est. completion date: January 2004

Study information

• Verified date: June 2013
• Source: Watching Over Mothers & Babies Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy
• Smoking Cessation

Intervention

Drug:
• Bupropion SR
Comparison of bupropion SR or placebo + smoking cessation counseling
• placebo

Behavioral:
• smoking cessation counseling

Locations

Country	Name	City	State
United States	Watching over Mothers and Babies Foundation	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Watching Over Mothers & Babies Foundation	University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	depression	change in depression (measured by the Edinburgh postnatal depression scale) between study enrollment and end of treatment (8 weeks)	8 weeks and delivery	No
Primary	biologically verified smoking cessation or reduction	change in smoking from study enrollment to end of treatment (8 weeks) and at delivery	8 weeks and delivery	No
Secondary	adverse events reported during pregnancy		8 weeks and delivery	Yes
Secondary	self reported smoking cessation or reduction	change in self reported smoking from study enrollment to end of treatment (8 weeks) and at delivery	8 weeks and delivery	No