Clinical trial NCT01286402: Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy
Official title: Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Keywords: Smoking cessation during pregnancy
bupropion
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
name: Gilstrap, Larry C, M.D.
name: The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
First posted: 2011-01-31
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to gather preliminary effectiveness and safety data on the use of bupropion for smoking cessation in pregnant women attending a community prenatal clinic. This study will provide critical preliminary data in preparation for a larger, Phase III clinical trial.

Detailed description: A randomized, double-blind, parallel group design will be used to allow a rigorous preliminary assessment of the feasibility, effectiveness, and safety of bupropion SR (sustained release; packaged as Zyban by GlaxoSmithKline) in promoting smoking cessation among women in their second and third trimester of pregnancy. Fifty pregnant smokers will be randomized to receive an 8-week course of either bupropion SR or matching placebo tablets. Both groups will receive evidence-based smoking cessation counseling. The primary smoking outcome will be 7-day point prevalence abstinence with cotinine validation at the end of the treatment. Secondary outcomes include enrollment, retention, and compliance rates; continuous abstinence from end of treatment through the 2 week followup; continuous abstinence from birth to 2nd week postpartum followup; self-reported reduction in number of cigarettes smoked per day; and maternal side effects and perinatal/neonatal outcomes. Preliminary smoking cessation and safety outcomes will be assessed for the generation of evidence-based hypotheses regarding clinical benefit of bupropion for pregnant smokers in preparation fo a larger trial.

Eligibility criteria: Inclusion Criteria:

* Pregnant women ≥ 18 years of age
* Gestational age between 14 and 26 weeks confirmed by ultrasound
* Currently smoking ≥ 5 cigarettes per day

Exclusion Criteria:

* Abnormal liver function tests
* History of or current seizure disorder or closed head injury with loss of consciousness
* Known hypersensitivity to bupropion
* Any psychiatric disorder requiring psychotropic medication
* Current anorexia or bulimia
* Use of monoamine oxidase (MAO) inhibitors or discontinuation within the past 2 weeks
* Major Depressive Disorder or current suicidal risk
* Use of any illicit substances since receiving knowledge of pregnancy
* Regular use of alcohol (\>1 drink/week on average)
* Unstable medical problems, such as liver or renal disease, uncontrollable hypertension, and lupus
* Twins or other multiple gestation
* Fetal abnormality on the 14 week ultrasound
* Plans to deliver at a hospital other than Memorial Hermann
* Inability to communicate with research staff or make study visits due to lack of phone or transportation access
* Participation in another clinical study which may affect study outcomes
* Current use of any Nicotine Replacement Therapy (NRT), bupropion, or varenicline (Chantix)

Primary outcomes:
measure: 7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment
timeFrame: 1 week post treatment
Secondary outcomes:
measure: Enrollment, Retention and Compliance Rates
timeFrame: 1 year (estimated)
measure: Continuous Abstinence From End of Treatment Through the 2 Week Followup
timeFrame: at two week followup visit
measure: Continuous Abstinence From Birth to 2nd Week Postpartum Followup
timeFrame: at 2nd week postpartum followup visit
measure: Self-reported Reduction in Number of Cigarettes Smoked Per Day
timeFrame: at 1 week post treatment and at 2 week postpartum visit
measure: Maternal Side Effects
timeFrame: during treatment, end of treatment and at 2 week postpartum visit
measure: Perinatal/Neonatal Outcomes
timeFrame: at neonatal discharge from hospital following delivery
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston, Professional Building
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Angela L Stotts, PhD
role: PRINCIPAL_INVESTIGATOR
References: