Bupropion for Smoking Cessation During Pregnancy

NCT01390246 | Completed Phase 4 Results DMC

• 2 other identifiers: 10-217R01DA030998
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Tobacco Use Disorder

Keywords

Pregnancy; Tobacco use disorder; Smoking cessation; Bupropion SR; Zyban

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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

Study Arms (2)

Bupropion SR + cessation counseling

ACTIVE COMPARATOR

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.

Drug: Bupropion SR; Behavioral: Smoking Cessation Counseling

Placebo + cessation counseling

PLACEBO COMPARATOR

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.

Behavioral: Smoking Cessation Counseling; Drug: Placebo

Interventions

Bupropion SR DRUG

Bupropion SR 150 mg tablet

Also known as: Zyban, buproban

Bupropion SR + cessation counseling

Smoking Cessation Counseling BEHAVIORAL

35-min counseling by trained research nurse

Also known as: Behavioral counseling

Bupropion SR + cessation counseling; Placebo + cessation counseling

Placebo DRUG

Matching Bupropion SR placebo tablet

Also known as: Control

Placebo + cessation counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• smoking at least 10 CPD prior to pregnancy and 5 CPD for the preceding 7 days
• weeks gestation
• ≥18 years of age
• able to speak English or Spanish
• intent to carry pregnancy to term
• stable residence

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• National Institute on Drug Abuse (NIDA): collaborator
• UConn Health: collaborator

Study Sites (1)

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

Location

Related 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.ajog.2016.11.1036. Epub 2016 Nov 25.

  PMID: 27890648 RESULT

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Interventions

Bupropion; Behavior Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Factors affecting enrollment included social stigma of prenatal smoking and use of medications; high rate of early withdrawal/lost to follow since longitudinal

Results Point of Contact

• Title: Dr. Tatiana Nanovskaya, PhD
• Organization: University of Texas Medical Branch

tnnanovs@utmb.edu

409-772-3908

Study Officials

• Gary DV Hankins, MD

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

• Tatiana Nanovskaya, PhD

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

• Cheryl Onken, MD, MPH

  UConn Health

  PRINCIPAL INVESTIGATOR

• Mahmoud Ahmed, PhD

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

• Shannon Clark, MD

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: July 8, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 7, 2019
• Results First Posted: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)