Testing Pharmacological Therapies for Pregnant Smokers

Duke University

Status and phase: Terminated; Phase 4

Conditions: Smoking; Pregnancy

Treatments: Drug: CBT + NRT; Behavioral: Motivational interviewing for smoking cessation; Behavioral: Cognitive behaviors therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00224419

CA89053 (Other Identifier)

Duke University IRB #2865

Pro00007724

Details and patient eligibility

About

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.

Full 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.

Enrollment: 181 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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181 participants in 2 patient groups

1 - CBT Counseling

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cognitive behaviors therapy

Behavioral: Motivational interviewing for smoking cessation

2 - Counseling + NRT

Experimental group

Description:

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.

Treatment:

Behavioral: Motivational interviewing for smoking cessation

Drug: CBT + NRT