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Nicotine Replacement Treatment for Pregnant Smokers - 1

This study has been terminated.
( Efficacy rates did not show large enough differences between treatments )

Sponsored by: 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

MedlinePlus related topics:   Smoking    Smoking and Youth   

Drug Information available for:   Nicotine polacrilex    Nicotine tartrate   

U.S. FDA Resources

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

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
Estimated Study Completion Date:   December 2008
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

Investigators
Principal Investigator:     Cheryl A Oncken, M.D.     University of Connecticut    
  More Information


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

Publications indexed to this study:

Responsible Party:   University of Connecticut School of Medicine ( Cheryl Oncken, MD, MPH )
Study ID Numbers:   NIDA-15167-1, R01-15167-1
First Received:   June 23, 2005
Last Updated:   August 14, 2008
ClinicalTrials.gov Identifier:   NCT00115687
Health Authority:   United States: Federal Government;   United States: Food and Drug Administration

Study placed in the following topic categories:
Nicotine polacrilex
Nicotine
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

Additional relevant MeSH terms:
Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Agonists
Physiological Effects of Drugs
Central Nervous System Stimulants
Cholinergic Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Ganglionic Stimulants
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2008




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