Bupropion for Smoking Cessation During Pregnancy

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: National Institute on Drug Abuse (NIDA); UConn Health
• Treatments: Bupropion

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)