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Testing Pharmacological Therapies for Pregnant Smokers

Phase 4
18 Years
Not Enrolling
Smoking, Pregnancy

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Trial Information

Testing Pharmacological Therapies for Pregnant Smokers

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.

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

- Complications of pregnancy during the current pregnancy, including: threatened
miscarriage, congenital anomalies, unexplained vaginal bleeding, pelvic or abdominal
surgical procedures, deep venous thrombosis, malignancy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biochemically-validated smoking cessation

Outcome Time Frame:

middle and late pregnancy

Safety Issue:


Principal Investigator

Evan Myers, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Food and Drug Administration

Study ID:




Start Date:

June 2003

Completion Date:

Related Keywords:

  • Smoking
  • Pregnancy
  • Smoking cessation
  • Pregnancy
  • Nicotine replacement therapy
  • Motivational interviewing
  • Smoking



Duke University Medical Center Durham, North Carolina  27710
Womack Army Medical Center Fayetteville, North Carolina  28310