Nicotine Replacement Treatment for Pregnant Smokers - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00115687
Recruitment Status : Terminated (Efficacy rates did not show large enough differences between treatments)
First Posted : June 24, 2005
Last Update Posted : January 12, 2017
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:

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 or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: placebo Drug: 2 mg nicotine polacrilex Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Nicotine Replacement Treatment for Pregnant Smokers
Study Start Date : June 2002
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: A
Drug: placebo
Experimental: B
2 mg nicotine gum
Drug: 2 mg nicotine polacrilex

Primary Outcome Measures :
  1. Biochemically validated quit rates [ Time Frame: 6 weeks after treatment, end of pregnancy ]

Secondary Outcome Measures :
  1. tobacco exposure measurements [ Time Frame: 6 weeks after treatment, end of pregnancy ]
  2. birth weight [ Time Frame: time of delivery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00115687

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Hartford Hospital
Hartford, Connecticut, United States, 06106
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: Cheryl A Oncken, M.D. UConn Health

Additional Information:
Publications of Results:
Responsible Party: Cheryl Oncken, MD, MPH, University of Connecticut School of Medicine Identifier: NCT00115687     History of Changes
Obsolete Identifiers: NCT00064948
Other Study ID Numbers: NIDA-15167-1
First Posted: June 24, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: May 2010

Keywords provided by National Institute on Drug Abuse (NIDA):
nicotine addiction

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action