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NCT00218465 · ClinicalTrials.gov registry record · Phase 2

Effectiveness of GW468816, an NMDA Glycine Site Antagonist, for Prevention of Relapse to Smoking

A Phase 2 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 2
Development phase
264
Enrollment target

NCT00218465: Completed Phase 2 study, sponsored by Massachusetts General Hospital.

NCT00218465 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 264 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00218465, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 2
Development phase
264 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy of the glycine antagonist, GW468816, compared with placebo on duration of abstinence and rates of relapse in recently quit female smokers in a randomized, double-blind, five-week clinical trial. According to the investigators, the new medication, GW468816, is thought to send certain signals in the brain that may be effective in helping people stay abstinent after they have recently quit smoking. GW468816 is a non-nicotine drug. The investigators of this study hypothesize that subjects receiving GW468816 will demonstrate a significantly longer time to relapse to smoking than those in the placebo group, as measured by the primary outcome measure (see below).

Interventions

  • DRUG Placebo Comparator: Placebo
  • DRUG GW468816

Trial Details

FieldValue
Enrollment Target 264 participants
Start Date 2006-08
Est. Completion 2009-06
Phase Phase 2
Massachusetts General Hospital

2,032 total trials

What the finished NCT00218465 record still lists

NCT00218465 is an interventional study that assigns participants to a tested intervention. The registered 264 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 (98% higher).

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

NCT00218465 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00218465 about?

NCT00218465 is a clinical study titled "Effectiveness of GW468816, an NMDA Glycine Site Antagonist, for Prevention of Relapse to Smoking". The purpose of this study is to evaluate the efficacy of the glycine antagonist, GW468816, compared with placebo on duration of abstinence and rates of relapse in recently quit female smokers in a randomized, double-blind, five-week clinical trial. According to the investigators, the new medication...

What is the current status of trial NCT00218465?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 264 participants. The study started on 2006-08. Estimated completion is 2009-06.

What interventions are being tested in trial NCT00218465?

The interventions under investigation include: Placebo Comparator: Placebo (DRUG), GW468816 (DRUG).

Who is sponsoring clinical trial NCT00218465?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00218465's enrollment target sits among peer trials

264 210th of 2000 higher than 1,791 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 NCT00218465, the US trial registry maintained by the National Library of Medicine. NCT00218465 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.