Nicotine Replacement Treatment for Pregnant Smokers - 1 - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00115687

Purpose

Smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes. Even with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely exceed 20%. These low quit rates may be due to inadequate treatment of the physical dependence on nicotine. Indeed, medications, which may help to reduce nicotine withdrawal symptoms, are a first-line treatment for smoking treatment in non-pregnant smokers. However, little information is available on the safety or efficacy of medications to treat pregnant smokers.

The purpose of this trial is to evaluate the safety and effectiveness of 2 mg nicotine gum in promoting smoking cessation during pregnancy. The design is a randomized, placebo controlled trial where subjects are randomized to nicotine gum (6 weeks ad libitum use followed by a 6 week taper) or a matching placebo. Women who are doing well at the end of the trial will also be offered gum post-partum for relapse prevention.

Condition	Intervention	Phase
Tobacco Use Disorder	Drug: placebo Drug: 2 mg nicotine polacrilex	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Nicotine Replacement Treatment for Pregnant Smokers

Resource links provided by NLM:

MedlinePlus related topics: Smoking Smoking and Youth

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Biochemically validated quit rates [ Time Frame: 6 weeks after treatment, end of pregnancy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

tobacco exposure measurements [ Time Frame: 6 weeks after treatment, end of pregnancy ] [ Designated as safety issue: Yes ]
birth weight [ Time Frame: time of delivery ] [ Designated as safety issue: Yes ]

Enrollment:	250
Study Start Date:	June 2002
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator placebo	Drug: placebo
B: Experimental 2 mg nicotine gum	Drug: 2 mg nicotine polacrilex

Detailed Description:

This proposal will examine the utility of one first-line medication, nicotine gum, as an aid to smoking cessation during pregnancy.

The specific aims are:

(1) To compare smoking cessation rates and smoking reduction among pregnant smokers who are randomized to receive nicotine gum (2 mg dose) or a matching placebo;
(2) To compare nicotine gum versus placebo on surrogate measures of maternal and fetal safety (i.e., overall nicotine and tobacco exposure at 6 weeks after the quit date and at 32-34 weeks gestation) and birth weight at the time of delivery;
(3) To examine which subjects benefit the most from the use of nicotine gum for smoking cessation during pregnancy.

Subjects will be recruited from prenatal clinics that serve primarily a low-income, minority population. Two hundred sixty-eight pregnant smokers will be randomly assigned to receive smoking cessation behavioral counseling and either a 6-week course of mint flavored placebo or nicotine gum, followed by 6 weeks of decreasing doses. Maternal blood for genotyping will be obtained at study entry. Primary outcome measures will be 7-day point prevalence of cigarette abstinence, number of cigarettes smoked per day, urinary cotinine concentrations, and measures of tobacco exposure (i.e., carbon monoxide in exhaled air and urine anabasine and anatabine) at 6 weeks after the quit date and at 32-34 weeks gestation, and infant birth weight. We hypothesize that:

(1) Pregnant smokers who are randomized to nicotine gum will have double the quit rates and will reduce their smoking to a greater degree than subjects randomized to placebo;
(2) Nicotine gum compared to placebo will reduce maternal levels of tobacco-exposure markers and increase birth weights in the offspring;
(3) The odds of cigarette abstinence will be increased primarily in subjects who smoke at least 15 cigarettes per day.

Eligibility

Ages Eligible for Study:	16 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient's gestational age is 26 weeks or less.
Patient is at least 16 years of age.
Patient is able to speak English or Spanish.
Patient intends to carry to term.
Patient has stable residence.
Patient has smoked five or more cigarettes everyday for the past seven days.

Exclusion Criteria:

Evidence that the patient is pregnant with a fetus with a known congenital abnormality.
Unstable medical problems (i.e., hyperthyroidism, temporomandibular joint disorder, pre-eclampsia, threatened abortion, hyperemesis gravidarum)
Multiple Gestation
Unstable psychiatric disorder
Current drug or alcohol abuse or dependence

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115687

Locations

United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06106
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Cheryl A Oncken, M.D.

University of Connecticut Health Center

More Information

Additional Information:

To read a newspaper article about the Nicotine Replacement Treatment for Pregnant Smokers study, click here This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Oncken C, Dornelas E, Greene J, Sankey H, Glasmann A, Feinn R, Kranzler HR. Nicotine gum for pregnant smokers: a randomized controlled trial. Obstet Gynecol. 2008 Oct;112(4):859-67.

Responsible Party:	University of Connecticut School of Medicine ( Cheryl Oncken, MD, MPH )
Study ID Numbers:	NIDA-15167-1, R01-15167-1, DPMCDA
Study First Received:	June 23, 2005
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00115687 History of Changes
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Additional relevant MeSH terms:

Nicotine polacrilex
Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Tobacco Use Disorder
Nicotinic Agonists
Physiological Effects of Drugs
Disorders of Environmental Origin
Central Nervous System Stimulants
Cholinergic Agents

Pharmacologic Actions
Autonomic Agents
Mental Disorders
Nicotine
Therapeutic Uses
Ganglionic Stimulants
Substance-Related Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009