Bupropion for Smoking Cessation During Pregnancy

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Tobacco Use Disorder; Pregnancy Related

Treatments: Behavioral: Smoking Cessation Counseling; Drug: Placebo; Drug: Bupropion SR

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01390246

10-217

R01DA030998 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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. 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 regardless 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 postpartum period. Subject participation will begin between 13-30 wks of gestation and end 6 months postpartum. Participation will be ten (10) to thirteen(13) months in length.

Enrollment: 65 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups, including a placebo group

Bupropion SR + cessation counseling

Active Comparator group

Description:

Bupropion SR and smoking cessation counseling Subjects received Bupropion SR 150 mg tablet orally twice daily (BID) for 12 weeks. Subjects were instructed to begin using study medication (bupropion SR 150 mg orally for 3 days, then BID for 4 days) on study visit day 1, which was approximately 1 week prior to their quit date. Thereafter, they were continued to dose Bupropion SR 150 mg tablet orally BID for a total medication treatment of 12 full weeks. Smoking cessation counseling included 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the trained study nurse.

Treatment:

Drug: Bupropion SR

Behavioral: Smoking Cessation Counseling

Placebo + cessation counseling

Placebo Comparator group

Description:

Placebo and smoking cessation counseling Subjects received matching Bupropion SR placebo tablet orally twice daily (BID) for 12 weeks. Subjects were instructed to begin using study medication (matched placebo tablets orally for 3 days, then BID for 4 days) on study visit day 1, which was approximately 1 week prior to their quit date. Thereafter, they were continued to dose matching Bupropion SR placebo tablet orally BID for a total medication treatment of 12 full weeks of therapy. Smoking cessation counseling included 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the trained study nurse.

Treatment:

Drug: Placebo

Behavioral: Smoking Cessation Counseling