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Testing Pharmacological Therapies for Pregnant Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00224419
Recruitment Status : Terminated (was terminated due to meeting a priori stopping rule set by DSMB)
First Posted : September 23, 2005
Last Update Posted : July 21, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Duke University

Brief Summary:
Nicotine dependence has not been sufficiently addressed in current state-of-the-science cessation interventions for pregnant smokers. The weight of the evidence from the general population of smokers suggests that nicotine replacement therapies may be beneficial cessation aids for pregnant smokers who are unable to stop smoking. The tremendous potential of these therapies for promoting smoking cessation among pregnant women creates a pressing need for decision tools and protocols to encourage treatment adherence that is essential for rigorous evaluation of the effectiveness of OTC NRT when provided as part of prenatal care. The results of this research could be directly translated to the improvement of obstetrical care providers' clinical practices. Medically supervised use of OTC NRT by pregnant smokers is an alternative to continued smoking that has the potential to substantially increase rates of smoking cessation during pregnancy.

Condition or disease Intervention/treatment Phase
Smoking Pregnancy Behavioral: Motivational interviewing for smoking cessation Behavioral: Cognitive behaviors therapy Drug: CBT + NRT Phase 4

Detailed Description:
The proposed five-year study is designed to evaluate the effectiveness of providing over-the-counter (OTC) nicotine replacement therapy, choice of gum, lozenge or patch, (NRT) to promote prepartum smoking cessation. Proposed is a two-arm design. Eligible pregnant women (N=300) will be randomized to either: Arm 1, Tailored Cognitive Behavioral Treatment (TCBT, n=100) that provides women with customized risk information about smoking and nicotine, the potential harms to the fetus and encouragement of appropriate behavioral skills building; or Arm 2, TCBT + NRT - the tailored intervention incorporating NRT information plus choice of patch or gum (n=200). The intervention will include 5 face-to-face contacts as part of prenatal visits and 1 telephone counseling session. Primary outcome measures will be biochemically validated 7-day prevalent abstinence rates at the 19-27th and 29-37th week of pregnancy. Secondary outcomes will include 7-day prevalent abstinence rates at 12 weeks postpartum, serious quit attempts, compliance with NRT, and use of materials. Saliva cotinine will be measured among all women at baseline, the 27-35th week of pregnancy, and 12 weeks postpartum. The significance of this project is that it relies on transdisciplinary collaborations to extend the science in nicotine replacement therapies to a population that could derive substantial health benefits. Moreover, the study results have immediate potential to inform clinical recommendations for integrating nicotine replacement into prenatal care.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Testing Pharmacological Therapies for Pregnant Smokers
Study Start Date : June 2003
Actual Primary Completion Date : August 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1 - CBT Counseling
Participants in this arm received a tailored CBT (TCBT) intervention that included: a written self-help guide, feedback about the importance of reducing nicotine exposure to the fetus, 5 face to face and 1 telephone counseling session.
Behavioral: Motivational interviewing for smoking cessation
All participants received a tailored CBT (TCBT) intervention that included: a written self-help guide, info about the importance of reducing nicotine exposure to the fetus, 5 face to face and 1 telephone counseling session. Women in the TCBT + NRT arm were guided through a process of deciding on nicotine gum, lozenge or patch. To minimize fetal exposure, the dose of NRT was customized to the woman's current level of smoking. Women who smoked 5-10 cigarettes a day were given the 14 mg patch or instructed to use one 2 mg lozenge or 2 mg piece of gum to replace each cigarette she usually smoked per day. Those who smoked 11 cigarettes or more per day were given the 21 mg patch or instructed to use no more than one lozenge (2 mg) or piece of gum (2 mg) to replace each cigarette she usually smoked per day, not to exceed 15 lozenges or pieces of gum per day.
Other Names:
  • Nicoderm CQ (patch)
  • Nicorertte (gum)
  • Commit (lozenge)

Behavioral: Cognitive behaviors therapy
6 counseling sessions delivered over the phone or in person

Experimental: 2 - Counseling + NRT
Women in this arm received the TCBT described in Arm 1, plus their choice of NRT. To minimize fetal exposure to nicotine for women in the TCBT+NRT arm, the dose of NRT are customized to the woman's current level of smoking. Women who smoke 5-10 cigarettes a day will be given the 14 mg patch or instructed to use one 2 mg lozenge or 2 mg piece of gum to replace each cigarette she usually smokes per day. Those who smoke 11 cigarettes or more per day will be given the 21 mg patch or instructed to use no more than one lozenge (2 mg) or piece of gum (2 mg) to replace each cigarette she usually smokes per day, not to exceed 15 lozenges or pieces of gum per day.
Behavioral: Motivational interviewing for smoking cessation
All participants received a tailored CBT (TCBT) intervention that included: a written self-help guide, info about the importance of reducing nicotine exposure to the fetus, 5 face to face and 1 telephone counseling session. Women in the TCBT + NRT arm were guided through a process of deciding on nicotine gum, lozenge or patch. To minimize fetal exposure, the dose of NRT was customized to the woman's current level of smoking. Women who smoked 5-10 cigarettes a day were given the 14 mg patch or instructed to use one 2 mg lozenge or 2 mg piece of gum to replace each cigarette she usually smoked per day. Those who smoked 11 cigarettes or more per day were given the 21 mg patch or instructed to use no more than one lozenge (2 mg) or piece of gum (2 mg) to replace each cigarette she usually smoked per day, not to exceed 15 lozenges or pieces of gum per day.
Other Names:
  • Nicoderm CQ (patch)
  • Nicorertte (gum)
  • Commit (lozenge)

Drug: CBT + NRT
Includes CBT from arm 1 plus choice of NRT (lozenge, gum, or patch) tailored to smoking amount
Other Names:
  • Nicoderm CQ (patch)
  • Nicorette (gum)
  • Commit (lozenge)




Primary Outcome Measures :
  1. Biochemically-validated smoking cessation [ Time Frame: middle and late pregnancy ]

Secondary Outcome Measures :
  1. Biochemically-validated smoking cessation [ Time Frame: 3 months postpartum ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be at least 18 years of age
  • Be between 13 and 25 weeks of pregnancy
  • Be receiving prenatal care at one of the participating clinics
  • Have smoked at least 100 cigarettes in their lifetime
  • Be currently smoking and have smoked at least 5 cigarettes per day in the past 7 days
  • Speak and write English

Exclusion Criteria:

  • Evidence of cognitive or mental health problems
  • Evidence of possible drug or alcohol addiction
  • Documented history in medical chart of mental retardation, significant chronic or recurrent psychiatric disorder such as schizophrenia or severe depression, history of cardiac arrhythmias, history of myocardial infarction within the past 6 months, history of previous pregnancy with congenital anomaly,family history of congenital anomalies
  • Complications of pregnancy during the current pregnancy, including: threatened miscarriage, congenital anomalies, unexplained vaginal bleeding, pelvic or abdominal surgical procedures, deep venous thrombosis, malignancy

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): NCT00224419


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Womack Army Medical Center
Fayetteville, North Carolina, United States, 28310
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Evan Myers, MD, MPH Duke University

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kathryn Pollak, PhD, Duke University Department of Community and Family Medicine
ClinicalTrials.gov Identifier: NCT00224419    
Other Study ID Numbers: Pro00007724
Duke University IRB #2865
CA89053 ( Other Identifier: DUMC )
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: July 21, 2014
Last Verified: April 2009
Keywords provided by Duke University:
Smoking cessation
Pregnancy
Nicotine replacement therapy
Motivational interviewing
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action