Study Stopped
was terminated due to meeting a priori stopping rule set by DSMB
Testing Pharmacological Therapies for Pregnant Smokers
3 other identifiers
interventional
181
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 21, 2005
CompletedFirst Posted
Study publicly available on registry
September 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedJuly 21, 2014
April 1, 2009
3.2 years
September 21, 2005
July 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biochemically-validated smoking cessation
middle and late pregnancy
Secondary Outcomes (1)
Biochemically-validated smoking cessation
3 months postpartum
Study Arms (2)
1 - CBT Counseling
ACTIVE COMPARATORParticipants 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.
2 - Counseling + NRT
EXPERIMENTALWomen 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.
Interventions
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.
6 counseling sessions delivered over the phone or in person
Includes CBT from arm 1 plus choice of NRT (lozenge, gum, or patch) tailored to smoking amount
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Duke University Medical Center
Durham, North Carolina, 27710, United States
Womack Army Medical Center
Fayetteville, North Carolina, 28310, United States
Related Publications (5)
Pletsch PK, Pollak KI, Peterson BL, Park J, Oncken CA, Swamy GK, Lyna P. Olfactory and gustatory sensory changes to tobacco smoke in pregnant smokers. Res Nurs Health. 2008 Feb;31(1):31-41. doi: 10.1002/nur.20229.
PMID: 18161772BACKGROUNDPollak KI, Oncken CA, Lipkus IM, Peterson BL, Swamy GK, Pletsch PK, Lyna P, Namenek Brouwer RJ, Fish LJ, Myers ER. Challenges and solutions for recruiting pregnant smokers into a nicotine replacement therapy trial. Nicotine Tob Res. 2006 Aug;8(4):547-54. doi: 10.1080/14622200600789882.
PMID: 16920652BACKGROUNDBursey-Reddick, K, Swamy, GK, Brouwer, RN, Pollak, KI, Myers, ER. (2006). Comparison of Self-Reported Smoking Status and Anonymous Urinary Cotinine Testing in Pregnancy. American Journal of Obstetrics & Gynecology, 193 Supplement 6:S107.
BACKGROUNDPollak KI, Oncken CA, Lipkus IM, Lyna P, Swamy GK, Pletsch PK, Peterson BL, Heine RP, Brouwer RJ, Fish L, Myers ER. Nicotine replacement and behavioral therapy for smoking cessation in pregnancy. Am J Prev Med. 2007 Oct;33(4):297-305. doi: 10.1016/j.amepre.2007.05.006.
PMID: 17888856RESULTSwamy GK, Roelands JJ, Peterson BL, Fish LJ, Oncken CA, Pletsch PK, Myers ER, Whitecar PW, Pollak KI. Predictors of adverse events among pregnant smokers exposed in a nicotine replacement therapy trial. Am J Obstet Gynecol. 2009 Oct;201(4):354.e1-7. doi: 10.1016/j.ajog.2009.06.006. Epub 2009 Aug 7.
PMID: 19664750DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evan Myers, MD, MPH
Duke University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 21, 2005
First Posted
September 23, 2005
Study Start
June 1, 2003
Primary Completion
August 1, 2006
Last Updated
July 21, 2014
Record last verified: 2009-04