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NCT01188967 · ClinicalTrials.gov registry record · Phase 2
Effectiveness of GSK598809, a Selective D3 Antagonist, Added to CBT and NRT for Smoking Cessation and Relapse Prevention
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
NCT01188967: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT01188967 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01188967, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
Study Summary
The purpose of this research study is to find out if an investigational drug, GSK598809 can help people who have very recently quit smoking; the investigators want to find out if continuing to take GSK598809 over six weeks can help prevent smokers from relapsing. To relapse means you "fall back" into smoking again after quitting. The investigators also want to find out if GSK598809 is safe to take without causing too many side effects.
Primary Outcome
The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 4-week, continuous tobacco abstinence than those assigned to identical placebo at the end of the 6-week, double blind, treatment phase. Four-week continuous abstinence will be defined as Timeline Followback Calendar confirmation at study visit of smoking no cigarettes in the past 7 days, and expired air CO\<10ppm for 4 consecutive weeks (the last 4 weeks of the randomized phase)
Interventions
- DRUG Placebo
- DRUG GSK598809
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2010-08 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
What the finished NCT01188967 record still lists
NCT01188967 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01188967 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01188967 about?
NCT01188967 is a clinical study titled "Effectiveness of GSK598809, a Selective D3 Antagonist, Added to CBT and NRT for Smoking Cessation and Relapse Prevention". The purpose of this research study is to find out if an investigational drug, GSK598809 can help people who have very recently quit smoking; the investigators want to find out if continuing to take GSK598809 over six weeks can help prevent smokers from relapsing. To relapse means you "fall back" int...
What is the current status of trial NCT01188967?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2010-08. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01188967?
The interventions under investigation include: Placebo (DRUG), GSK598809 (DRUG).
Who is sponsoring clinical trial NCT01188967?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01188967's enrollment target sits among peer trials
84 822nd of 2000 higher than 1,173 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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