Bupropion for Smoking Cessation During Pregnancy

Pregnancy Related Clinical Trial

Official title:

Bupropion for Smoking Cessation During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390246
• Other study ID #: 10-217
• Secondary ID: R01DA030998
• Status: Completed
• Phase: Phase 4
• Start date: July 2011
• Est. completion date: December 2016

Study information

• Verified date: February 2018
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pregnancy Related
• Tobacco Use Disorder

Intervention

Drug:
• Bupropion SR
Bupropion SR 150 mg tablet

Behavioral:
• Smoking Cessation Counseling
35-min counseling by trained research nurse

Drug:
• Placebo
Matching Bupropion SR placebo tablet

Locations

Country	Name	City	State
United States	University of Texas Medical Branch at Galveston	Galveston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	National Institute on Drug Abuse (NIDA), UConn Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.aj — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups During Medication Treatment	Cigarette craving and withdrawal symptoms were assessed by the Minnesota Nicotine Withdrawal Scale (MNWS). MNWS consists of 7 objectives (e.g., irritability, anxious, depressed mood, difficulty concentrating, increased appetite, insomnia, restless). Subjects were given a score on each item on a scale of 0 (not present) to 4 (severe). Summed (total) score excluding craving represent subject's symptoms of tobacco withdrawal, ranging from 0 to 28. We calculated a craving for tobacco score and a total score of withdrawal symptoms excluding craving. The higher score represent more sever craving and withdrawal.	During treatment: Visits 2-6 (time period between 2nd and 12th week of therapy)
Primary	Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups on the Quit Date	Cigarette craving and withdrawal symptoms were assessed by the Minnesota Nicotine Withdrawal Scale (MNWS). MNWS consists of 7 objectives (e.g., irritability, anxious, depressed mood, difficulty concentrating, increased appetite, insomnia, restless). Subjects were given a score on each item on a scale of 0 (not present) to 4 (severe). Summed (total) score excluding craving represent subject's symptoms of tobacco withdrawal, ranging from 0 to 28. We calculated a craving for tobacco score and a total score of withdrawal symptoms excluding craving. The higher score represent more sever craving and withdrawal.	Quit date, visit 2 (one week after starting the 12-week course of therapy)
Primary	Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Medication Treatment (Visit 6)	The accuracy of self-reported smoking abstinence during study visits was confirmed by an exhaled carbon monoxide (CO) levels and by urinary cotinine levels. 7-day point prevalence abstinence was defined as no cigarettes (not even a puff) in the last 7 days, levels of (CO) in exhaled air < 4 ppm, and concentrations of cotinine in urine < 50 ng/mL. At every visit, a research nurse monitored the smoking status of all subjects (amount of cigarettes per day, exhaled CO). Exhaled CO was measured using a Vitalograph carbon monoxide monitor (Lenexa, KS) according to the manufacturer's recommendations. A urine sample was collected at each visit and cotinine in urine was quantified using the validated liquid chromatography-mass spectrometry (LC/MS) method. We calculated the total number of abstinent subjects. The higher the number the better outcome.	Visit 6 (end of 12 weeks of medication therapy)
Primary	Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Pregnancy (Visit 7)	The accuracy of self-reported smoking abstinence during study visits was confirmed by an exhaled carbon monoxide (CO) levels and by urinary cotinine levels. 7-day point prevalence abstinence was defined as no cigarettes (not even a puff) in the last 7 days, levels of (CO) in exhaled air < 4 ppm, and concentrations of cotinine in urine < 50 ng/mL. At every visit, a research nurse monitored the smoking status of all subjects (amount of cigarettes per day, exhaled CO). Exhaled CO was measured using a Vitalograph carbon monoxide monitor (Lenexa, KS) according to the manufacturer's recommendations. A urine sample was collected at each visit and cotinine in urine was quantified using the validated liquid chromatography-mass spectrometry (LC/MS) method. We calculated the total number of abstinent subjects. The higher the number the better outcome.	End of pregnancy (visit 7) is a time period between 36.0-38.6 weeks gestation