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NCT00224419 · ClinicalTrials.gov registry record · Phase 4

Testing Pharmacological Therapies for Pregnant Smokers

A Phase 4 study, sponsored by Duke University.

Terminated
Registry status
Phase 4
Development phase
181
Enrollment target

NCT00224419: Clinical Trial Phase 4 study, sponsored by Duke University.

NCT00224419 is a Phase 4 study that was terminated before completion, run by Duke University. The registered enrollment target is 181 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00224419, a Phase 4 study, was terminated before completion, sponsored by Duke University.

TERMINATED
Registry status
Phase 4
Development phase
181 participants
Enrollment target

Study Summary

Nicotine dependence has not been sufficiently addressed in current state-of-the-science cessation interventions for pregnant smokers. The weight of the evidence from the general population of smokers suggests that nicotine replacement therapies may be beneficial cessation aids for pregnant smokers who are unable to stop smoking. The tremendous potential of these therapies for promoting smoking cessation among pregnant women creates a pressing need for decision tools and protocols to encourage treatment adherence that is essential for rigorous evaluation of the effectiveness of OTC NRT when provided as part of prenatal care. The results of this research could be directly translated to the improvement of obstetrical care providers' clinical practices. Medically supervised use of OTC NRT by pregnant smokers is an alternative to continued smoking that has the potential to substantially increase rates of smoking cessation during pregnancy.

Interventions

  • BEHAVIORAL Motivational interviewing for smoking cessation
  • BEHAVIORAL Cognitive behaviors therapy
  • DRUG CBT + NRT

Trial Details

FieldValue
Enrollment Target 181 participants
Start Date 2003-06
Phase Phase 4
Duke University

1,725 total trials

Why NCT00224419 stopped before completion

NCT00224419 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 3 interventions - of which Motivational interviewing for smoking cessation is the first listed.

NCT00224419 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00224419 about?

NCT00224419 is a clinical study titled "Testing Pharmacological Therapies for Pregnant Smokers". Nicotine dependence has not been sufficiently addressed in current state-of-the-science cessation interventions for pregnant smokers. The weight of the evidence from the general population of smokers suggests that nicotine replacement therapies may be beneficial cessation aids for pregnant smokers w...

What is the current status of trial NCT00224419?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 181 participants. The study started on 2003-06.

What interventions are being tested in trial NCT00224419?

The interventions under investigation include: Motivational interviewing for smoking cessation (BEHAVIORAL), Cognitive behaviors therapy (BEHAVIORAL), CBT + NRT (DRUG).

Who is sponsoring clinical trial NCT00224419?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00224419's enrollment target sits among peer trials

181 464th of 2000 higher than 1,535 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00224419, the US trial registry maintained by the National Library of Medicine. NCT00224419 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.