Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Gilstrap, Larry C, M.D.; M.D. Anderson Cancer Center; The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
• Treatments: Bupropion

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)