Bupropion for Smoking Cessation During Pregnancy

Completed · Phase 4 · Has a placebo group

Conditions studied: Pregnancy Related, Tobacco Use Disorder

In brief

This is a prospective, double-blind placebo-controlled randomized pilot trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy.

Key facts

Study ID

NCT01390246

Run by

The University of Texas Medical Branch, Galveston

People needed

65

Starts

2011-07-01

Expected to finish

2016-12-01

Last updated by the study team

2019-06-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• smoking at least 10 CPD prior to pregnancy and 5 CPD for the preceding 7 days
• 13-30 weeks gestation
• ≥18 years of age
• able to speak English or Spanish
• intent to carry pregnancy to term
• stable residence

You may not qualify if…

• current illicit drug or alcohol abuse or dependence
• twins or other multiple gestation
• treatment for psychiatric disorder within the last 6 months
• unstable medical problems (eg, hypertension (BP>140/90), preeclampsia, threatened abortion, hyperemesis gravidarum)
• known congenital abnormality
• seizure disorder
• use of psychotropic medication
• use of medication known to lower the seizure threshold
• anorexia/bulimia
• a personal history of closed head trauma with > 30 minutes of loss of consciousness or amnesia or resulting in skull fracture or subdural hematoma/brain contusion
• use of any other smoking cessation treatment in the past 30 days
• current enrollment in methadone treatment program
• prior pregnancy with preeclampsia diagnosis
• chronic hypertension (past history or current diagnosis)

Where it is running

• University of Texas Medical Branch at Galveston — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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