Phase 2
Completed N=11
Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy
Source: ClinicalTrials.gov NCT01286402 ↗Enrolled (actual)
11
Serious AEs
18.2%
Results posted
Feb 2016
Primary outcomePrimary: 7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment — 0; 2 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment |
0; 2 | — |
| SECONDARY Enrollment, Retention and Compliance Rates |
— | — |
| SECONDARY Continuous Abstinence From End of Treatment Through the 2 Week Followup |
— | — |
| SECONDARY Continuous Abstinence From Birth to 2nd Week Postpartum Followup |
— | — |
| SECONDARY Self-reported Reduction in Number of Cigarettes Smoked Per Day |
— | — |
| SECONDARY Maternal Side Effects |
— | — |
| SECONDARY Perinatal/Neonatal Outcomes |
— | — |
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)
Data sourced from ClinicalTrials.gov (NCT01286402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.