Testing Pharmacological Therapies for Pregnant Smokers

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.

Conditions

• Smoking
• Pregnancy

Interventions

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.

BEHAVIORAL

Cognitive behaviors therapy

6 counseling sessions delivered over the phone or in person

DRUG

CBT + NRT

Includes CBT from arm 1 plus choice of NRT (lozenge, gum, or patch) tailored to smoking amount

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Duke University

  lead OTHER

Principal Investigators

• Evan Myers, MD, MPH · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2003-06-30

Primary Completion

2006-08-31

Countries

• United States

Study Locations