Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT01286402
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)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01286402
Study Brief:
Protocol Section:
NCT01286402