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NCT01406223 · ClinicalTrials.gov registry record · Phase 3

Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation

A Phase 3 study, sponsored by Duke University.

Completed
Registry status
Phase 3
Development phase
282
Enrollment target

NCT01406223: Completed Phase 3 study, sponsored by Duke University.

NCT01406223 is a Phase 3 study that has completed, run by Duke University. The registered enrollment target is 282 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01406223, a Phase 3 study, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 3
Development phase
282 participants
Enrollment target

Study Summary

The purpose of this study is to look at brain function in order to understand how different treatments work to help people quit smoking. In this study, the investigators will look at the effects of nicotine patches, Chantix alone or Chantix paired with Zyban.

Primary Outcome

Mean blood-oxygen-level dependent (BOLD) contrast sensitive functional magnetic resonance imaging (fMRI) cue-reactivity signal following 2 week pre-quit treatment, controlling for baseline cue-reactivity.

Interventions

  • DRUG Varenicline
  • DRUG Bupropion
  • DRUG Nicotine patches
  • OTHER Placebo varenicline
  • OTHER Placebo bupropion

Trial Details

FieldValue
Enrollment Target 282 participants
Start Date 2011-07
Est. Completion 2014-06
Phase Phase 3
Duke University

1,725 total trials

What the finished NCT01406223 record still lists

NCT01406223 is an interventional study that assigns participants to a tested intervention. The registered 282 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).

The record links to 0 conditions, and to 5 interventions - of which Varenicline is the first listed.

NCT01406223 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01406223 about?

NCT01406223 is a clinical study titled "Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation". The purpose of this study is to look at brain function in order to understand how different treatments work to help people quit smoking. In this study, the investigators will look at the effects of nicotine patches, Chantix alone or Chantix paired with Zyban.

What is the current status of trial NCT01406223?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 282 participants. The study started on 2011-07. Estimated completion is 2014-06.

What interventions are being tested in trial NCT01406223?

The interventions under investigation include: Varenicline (DRUG), Bupropion (DRUG), Nicotine patches (DRUG), Placebo varenicline (OTHER), Placebo bupropion (OTHER).

Who is sponsoring clinical trial NCT01406223?

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 NCT01406223's enrollment target sits among peer trials

282 1194th of 2000 higher than 807 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01406223, the US trial registry maintained by the National Library of Medicine. NCT01406223 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.