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Bupropion for Smoking Cessation During Pregnancy

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ClinicalTrials.gov Identifier: NCT01390246
Recruitment Status : Completed
First Posted : July 8, 2011
Results First Posted : February 13, 2018
Last Update Posted : March 16, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
UConn Health
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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.

Condition or disease Intervention/treatment Phase
Pregnancy Related Tobacco Use Disorder Drug: Bupropion SR Behavioral: Smoking Cessation Counseling Drug: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bupropion for Smoking Cessation During Pregnancy
Study Start Date : July 2011
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Bupropion SR + cessation counseling

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
Bupropion SR 150 mg tablet
Other Names:
  • Zyban
  • buproban
Behavioral: Smoking Cessation Counseling
35-min counseling by trained research nurse
Other Name: Behavioral counseling
Placebo Comparator: Placebo + cessation counseling

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
35-min counseling by trained research nurse
Other Name: Behavioral counseling
Drug: Placebo
Matching Bupropion SR placebo tablet
Other Name: Control



Primary Outcome Measures :
  1. Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups During Medication Treatment [ Time Frame: During treatment: Visits 2-6 (time period between 2nd and 12th week of therapy) ]
    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.

  2. Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups on the Quit Date [ Time Frame: Quit date, visit 2 (one week after starting the 12-week course of therapy) ]
    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.

  3. Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Medication Treatment (Visit 6) [ Time Frame: Visit 6 (end of 12 weeks of medication therapy) ]
    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.

  4. Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Pregnancy (Visit 7) [ Time Frame: End of pregnancy (visit 7) is a time period between 36.0-38.6 weeks gestation ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390246


Locations
United States, Texas
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
National Institute on Drug Abuse (NIDA)
UConn Health
Investigators
Principal Investigator: Gary DV Hankins, MD University of Texas Medical Branch at Galveston
Principal Investigator: Tatiana Nanovskaya, PhD University of Texas Medical Branch at Galveston
Principal Investigator: Cheryl Onken, MD, MPH UConn Health
Principal Investigator: Mahmoud Ahmed, PhD University of Texas Medical Branch at Galveston
Principal Investigator: Shannon Clark, MD University of Texas Medical Branch at Galveston

Publications of Results:
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT01390246     History of Changes
Other Study ID Numbers: 10-217
R01DA030998 ( U.S. NIH Grant/Contract )
First Posted: July 8, 2011    Key Record Dates
Results First Posted: February 13, 2018
Last Update Posted: March 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan

Keywords provided by The University of Texas Medical Branch, Galveston:
Pregnancy
Tobacco use disorder
Smoking cessation
Bupropion SR
Zyban

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors