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Bupropion for Smoking Cessation During Pregnancy

Information source: The University of Texas, Galveston
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pregnancy Related; Tobacco Use Disorder

Intervention: bupropion SR 150 mg tablets or matched placebo (Drug); Smoking Cessation Counseling (Behavioral)

Phase: Phase 4

Status: Recruiting

Sponsored by: The University of Texas, Galveston

Official(s) and/or principal investigator(s):
Gary DV Hankins, MD, Principal Investigator, Affiliation: University of Texas Medical Branch at Galveston
Tatiana Nanovskaya, PhD, Principal Investigator, Affiliation: University of Texas Medical Branch at Galveston

Overall contact:
Aimee L Jackson, MSN, WHNP-BC, Phone: 409-747-6647, Email: aijackso@utmb.edu

Summary

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

Clinical Details

Official title: Bupropion for Smoking Cessation During Pregnancy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Minnesota Nicotine Withdrawal Scale

Secondary outcome:

7-day point prevalence smoking abstinence

7-day point prevalence smoking abstinence

Detailed description: This is a prospective, double-blind placebo-controlled randomized controlled trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy. A total of 150 pregnant smokers will receive medication (75) or placebo (75) for 12 weeks. Compassionate care/continuance of therapy will be available to pregnant subjects. Women who relapse to smoking postpartum will be offered an additional course of medication treatment. All subjects irregardless of adherence with 12 week study drug administration period and smoking habits during pregnancy will be followed through the duration of their pregnancy, delivery, and 6-month post partum period. Subject participation will begin between 13-26 wks of gestation and end 6 months postpartum. Participation will be ten (10) to thirteen(13)months in length.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- smoking at least 10 CPD prior to pregnancy and 5 CPD for the preceding 7 days

- 13-26 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

Locations and Contacts

Aimee L Jackson, MSN, WHNP-BC, Phone: 409-747-6647, Email: aijackso@utmb.edu

University of Texas Medical Branch at Galveston, Galveston, Texas 77555, United States; Recruiting
Aimee L Jackson, WHNP-BC, MSN
Gary DV Hankins, MD, Principal Investigator
Tatiana Nanovskaya, PhD, Principal Investigator
Additional Information

Starting date: July 2011
Last updated: June 5, 2012

Page last updated: February 07, 2013

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