Clinical trial NCT01390246: Bupropion for Smoking Cessation During Pregnancy
Official title: Bupropion for Smoking Cessation During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy Related
Tobacco Use Disorder
Keywords: Pregnancy
Tobacco use disorder
Smoking cessation
Bupropion SR
Zyban
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: UConn Health
First posted: 2011-07-08
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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)

Primary outcomes:
measure: Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups During Medication Treatment
timeFrame: During treatment: Visits 2-6 (time period between 2nd and 12th week of therapy)
measure: Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups on the Quit Date
timeFrame: Quit date, visit 2 (one week after starting the 12-week course of therapy)
measure: Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Medication Treatment (Visit 6)
timeFrame: Visit 6 (end of 12 weeks of medication therapy)
measure: Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Pregnancy (Visit 7)
timeFrame: End of pregnancy (visit 7) is a time period between 36.0-38.6 weeks gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
Study officials:
affiliation: University of Texas Medical Branch at Galveston
name: Gary DV Hankins, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Medical Branch at Galveston
name: Tatiana Nanovskaya, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UConn Health
name: Cheryl Onken, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Medical Branch at Galveston
name: Mahmoud Ahmed, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Medical Branch at Galveston
name: Shannon Clark, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nanovskaya TN, Oncken C, Fokina VM, Feinn RS, Clark SM, West H, Jain SK, Ahmed MS, Hankins GDV. Bupropion sustained release for pregnant smokers: a randomized, placebo-controlled trial. Am J Obstet Gynecol. 2017 Apr;216(4):420.e1-420.e9. doi: 10.1016/j.ajog.2016.11.1036. Epub 2016 Nov 25.