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NCT01466361 · ClinicalTrials.gov registry record · Phase 2

Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
187
Enrollment target

NCT01466361: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT01466361 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 187 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01466361, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
187 participants
Enrollment target

Study Summary

This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a cigarette compared to a matched placebo (a placebo is like sugar pill and contains no active).

Primary Outcome

Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.

Interventions

  • DRUG Placebo
  • DRUG Nicotine lower dose
  • DRUG Nicotine higher dose

Trial Details

FieldValue
Enrollment Target 187 participants
Start Date 2010-09
Est. Completion 2010-12
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT01466361 record still lists

NCT01466361 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01466361 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01466361 about?

NCT01466361 is a clinical study titled "Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving". This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a cigarette compared to a matched placebo (a placebo is like sugar pill and contains no active).

What is the current status of trial NCT01466361?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 187 participants. The study started on 2010-09. Estimated completion is 2010-12.

What interventions are being tested in trial NCT01466361?

The interventions under investigation include: Placebo (DRUG), Nicotine lower dose (DRUG), Nicotine higher dose (DRUG).

Who is sponsoring clinical trial NCT01466361?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01466361's enrollment target sits among peer trials

187 357th of 2000 higher than 1,644 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01466361, the US trial registry maintained by the National Library of Medicine. NCT01466361 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.