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Nicotine Replacement Treatment for Pregnant Smokers - 1

NCT00115687 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2017-01-12

No results posted yet for this study

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.

Conditions

  • Tobacco Use Disorder

Interventions

DRUG

placebo

DRUG

2 mg nicotine polacrilex

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Cheryl A Oncken, M.D. · UConn Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00115687 on ClinicalTrials.gov