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NCT00749944 · ClinicalTrials.gov registry record · Phase 4

Assessing Neuropsychiatric Symptoms Including Depression, Anxiety, Irritability, and Suicidal Thoughts or Behavior in Subjects Quitting Smoking on Varenicline Tartrate or Placebo

A Phase 4 study, sponsored by Pfizer.

Completed
Registry status
Phase 4
Development phase
110
Enrollment target

NCT00749944: Completed Phase 4 study, sponsored by Pfizer.

NCT00749944 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 110 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00749944, a Phase 4 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 4
Development phase
110 participants
Enrollment target

Study Summary

Study objective is to compare neuropsychiatric adverse events in subjects treated with varenicline or placebo in a controlled setting where both groups are experiencing nicotine withdrawal.

Primary Outcome

POMS TMD were responses to 65 items in 6 subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor, Fatigue, and Confusion), on 'How you feel right now?' (scale:0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely). All items were rated in the same direction except for Relaxed and Efficient in the Tension-Anxiety and Confusion subscales. TMD was the sum of the scores of all 6 subscales but weighting Vigor negatively. Summary results (TMD scores) were presented as tra

Interventions

  • DRUG placebo
  • DRUG varenicline

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2008-09
Est. Completion 2009-08
Phase Phase 4
Pfizer

1,845 total trials

What the finished NCT00749944 record still lists

NCT00749944 is an interventional study that assigns participants to a tested intervention. The registered 110 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 (79% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00749944 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00749944 about?

NCT00749944 is a clinical study titled "Assessing Neuropsychiatric Symptoms Including Depression, Anxiety, Irritability, and Suicidal Thoughts or Behavior in Subjects Quitting Smoking on Varenicline Tartrate or Placebo". Study objective is to compare neuropsychiatric adverse events in subjects treated with varenicline or placebo in a controlled setting where both groups are experiencing nicotine withdrawal.

What is the current status of trial NCT00749944?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 2008-09. Estimated completion is 2009-08.

What interventions are being tested in trial NCT00749944?

The interventions under investigation include: placebo (DRUG), varenicline (DRUG).

Who is sponsoring clinical trial NCT00749944?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00749944's enrollment target sits among peer trials

110 727th of 2000 higher than 1,264 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 NCT00749944, the US trial registry maintained by the National Library of Medicine. NCT00749944 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.