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Bupropion for Smoking Cessation During Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by The University of Texas, Galveston
Sponsor:
Collaborators:
University of Connecticut Health Center
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT01390246
First received: June 8, 2011
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

This is a prospective, double-blind placebo-controlled randomized controlled trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy.


Condition Intervention Phase
Pregnancy Related
Tobacco Use Disorder
Drug: bupropion SR 150 mg tablets or matched placebo
Behavioral: Smoking Cessation Counseling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bupropion for Smoking Cessation During Pregnancy

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Minnesota Nicotine Withdrawal Scale [ Time Frame: Completion of study therapy (12 wks study treatment) ] [ Designated as safety issue: No ]
    The MNWS will be used to assess for change in withdrawal symptoms from the quit date (onset of smoking cessation + after 1 wk of treatment) to that at the completion of study therapy (status post 12 wks of study treatment, 11 wks post quit date).


Secondary Outcome Measures:
  • 7-day point prevalence smoking abstinence [ Time Frame: 3 weeks post quit date (post 12 weeks of study therapy) ] [ Designated as safety issue: No ]
    Abstinence, that is quit rate, measured via 7-day point prevalence abstinence will be assessed at the end of study medication treatment, that is post 12 weeks of study drug treatment and again at end of pregnancy (36.0-38.6 weeks of gestation). This outcome will be assessed twice to determine a change in the quit rate from immediately status post treatment to that which occurs immediately before delivery.

  • 7-day point prevalence smoking abstinence [ Time Frame: 36.0-38.6 wks gestation ] [ Designated as safety issue: No ]
    To assess change from immediately post treatment to that immediately prior to delivery.


Estimated Enrollment: 150
Study Start Date: July 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupropion SR
Bupropion SR 150 mg po BID. We will administer a 12-week course of therapy, 150 mg bid x 12 weeks. Subjects will be dispensed a 30 day supply at a time. They will be 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 will be approximately 1 week prior to their quit date. Thereafter, they will continue to dose BID for 12 full weeks of therapy.
Drug: bupropion SR 150 mg tablets or matched placebo
Bupropion SR tablets or matched placebo. We will administer a 12-week course of therapy, 150 mg bid/placebo x 12 weeks. Subjects will be dispensed a 30 day supply at a time. They will be instructed to begin using study medication (bupropion SR 150 mg/matched placebo orally for 3 days, then BID for 4 days) on study visit day 1, which will be approximately 1 week prior to their quit date. Thereafter, they will continue to dose BID for 12 full weeks of therapy.
Other Names:
  • Zyban
  • buproban
Behavioral: Smoking Cessation Counseling
The behavioral counseling will include 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the study nurse.
Other Name: behavioral counseling
Placebo Comparator: Placebo
We will administer a 12-week course of therapy, placebo bid x 12 weeks. Subjects will be dispensed a 30 day supply at a time. They will be instructed to begin using study medication (matched placebo tablets orally for 3 days, then BID for 4 days) on study visit day 1, which will be approximately 1 week prior to their quit date. Thereafter, they will continue to dose BID for 12 full weeks of therapy.
Drug: bupropion SR 150 mg tablets or matched placebo
Bupropion SR tablets or matched placebo. We will administer a 12-week course of therapy, 150 mg bid/placebo x 12 weeks. Subjects will be dispensed a 30 day supply at a time. They will be instructed to begin using study medication (bupropion SR 150 mg/matched placebo orally for 3 days, then BID for 4 days) on study visit day 1, which will be approximately 1 week prior to their quit date. Thereafter, they will continue to dose BID for 12 full weeks of therapy.
Other Names:
  • Zyban
  • buproban
Behavioral: Smoking Cessation Counseling
The behavioral counseling will include 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the study nurse.
Other Name: behavioral counseling

Detailed Description:

This is a prospective, double-blind placebo-controlled randomized controlled 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 irregardless 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 post partum period. Subject participation will begin between 13-26 wks of gestation and end 6 months postpartum. Participation will be ten (10) to thirteen(13)months in length.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  • 13-26 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390246

Contacts
Contact: Margaret Zimmerle, RN 409-747-8234 mlzimmer@utmb.edu
Contact: Janet Brandon, MSN 409-747-1733 jbrando@utmb.edu

Locations
United States, Texas
University of Texas Medical Branch at Galveston Recruiting
Galveston, Texas, United States, 77555
Contact: Margaret Zimmerle, RN       mlzimmer@utmb.edu   
Principal Investigator: Gary DV Hankins, MD         
Principal Investigator: Tatiana Nanovskaya, PhD         
Sponsors and Collaborators
The University of Texas, Galveston
University of Connecticut Health Center
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
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT01390246     History of Changes
Other Study ID Numbers: 10-217, R01DA030998-02
Study First Received: June 8, 2011
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Bupropion
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014