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NCT00960778 · ClinicalTrials.gov registry record · Phase 2

Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes

A Phase 2 study, sponsored by Medical University of South Carolina.

Completed
Registry status
Phase 2
Development phase
33
Enrollment target

NCT00960778 is a Phase 2 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 33 participants.

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The verdict

NCT00960778, a Phase 2 study, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
Phase 2
Development phase
33 participants
Enrollment target

Study Summary

This study will investigate the underlying neurobiology of differences between male and female smokers. Research suggests that women are less responsive to nicotine replacement therapy (NRT) than men and more responsive to the sensory and behavioral aspects of smoking. This study proposed that male smokers will have a greater response to NRT demonstrated by reduced withdrawal symptoms, craving, and less blood-oxygen-level dependent functional magnetic resonance imaging (BOLD FMRI) regional brain activation in response to nicotine-cues as compared to female smokers treated with NRT. Additionally, female smokers will have a greater response to denicotinized cigarettes with decreased withdrawal symptoms, craving, and less BOLD fMRI activation in response to nicotine-cues as compared to male smokers.

Interventions

  • DRUG nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol)
  • OTHER denicotinized cigarettes (Quest 3 cigarettes)

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2009-03
Est. Completion 2012-06
Phase Phase 2

What the Registry Record Tells You About NCT00960778

The ClinicalTrials.gov registry entry for NCT00960778 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol) is the first listed.

NCT00960778 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00960778 about?

NCT00960778 is a clinical study titled "Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes". This study will investigate the underlying neurobiology of differences between male and female smokers. Research suggests that women are less responsive to nicotine replacement therapy (NRT) than men and more responsive to the sensory and behavioral aspects of smoking. This study proposed that male ...

What is the current status of trial NCT00960778?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2009-03. Estimated completion is 2012-06.

What interventions are being tested in trial NCT00960778?

The interventions under investigation include: nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol) (DRUG), denicotinized cigarettes (Quest 3 cigarettes) (OTHER).

Who is sponsoring clinical trial NCT00960778?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.