Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy
Completed · Phase 2 · Has a placebo group
Conditions studied: Smoking Cessation
In brief
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.
Key facts
- Study ID
- NCT01286402
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 11
- Starts
- 2011-04-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2016-02-04
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Pregnant women ≥ 18 years of age
- Gestational age between 14 and 26 weeks confirmed by ultrasound
- Currently smoking ≥ 5 cigarettes per day
You may not qualify if…
- 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)
Where it is running
- University of Texas Health Science Center at Houston, Professional Building — Houston, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.