Testing Pharmacological Therapies for Pregnant Smokers

PHASE4TerminatedINTERVENTIONAL
Enrollment

181

Participants

Timeline

Start Date

June 30, 2003

Primary Completion Date

August 31, 2006

Conditions
SmokingPregnancy
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

Trial Locations (2)

27710

Duke University Medical Center, Durham

28310

Womack Army Medical Center, Fayetteville

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Duke University

OTHER