Clinical trial NCT01875172: Bupropion for Smoking Cessation in Pregnancy
Official title: Smoking Cessation in Pregnancy: A Pilot Study Comparing Counseling With and Without Sustained-Release Bupropion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Pregnancy
Keywords: bupropion SR
randomized controlled trial
pregnancy
Lead sponsor: Watching Over Mothers & Babies Foundation
Sponsor class: OTHER
Collaborators: name: University of Arizona
First posted: 2013-06-11
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: biologically verified smoking cessation or reduction
timeFrame: 8 weeks and delivery
Secondary outcomes:
measure: adverse events reported during pregnancy
timeFrame: 8 weeks and delivery
measure: self reported smoking cessation or reduction
timeFrame: 8 weeks and delivery
Other outcomes:
measure: depression
timeFrame: 8 weeks and delivery
Locations:
city: Tucson
country: United States
facility: Watching over Mothers and Babies Foundation
state: Arizona
Study officials:
affiliation: Watching Over Mothers and Babies Foundation
name: Hugh S Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: