CompletedPhase 2

Effectiveness of GSK598809, a Selective D3 Antagonist, Added to CBT and NRT for Smoking Cessation and Relapse Prevention

United States84 participantsStarted 2010-08

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Pregnant or able to become pregnant and not willing to use approved contraception.
. Breastfeeding or planning to breastfeed during the study or lactating within the month prior to enrollment.
. Has any of the following medical conditions/situations:
. Is unlikely to cooperate or unable to follow all of the procedures outlined in the protocol
. Use of tobacco-containing products other than cigarettes (e.g., cigar, pipe) and unwilling to discontinue use of these on the quit date.
. Abuse or dependence of any substance other than nicotine or caffeine in the past 6 months.
. Diagnosis of major depressive disorder in the past 6 months.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

4-week, Continuous Tobacco Abstinence at the End of the 6-week, Double Blind, Treatment Phase

Timeframe: Week 8 of the study

Trial details

NCT IDNCT01188967

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-05

Results submitted2015-04-07

View on ClinicalTrials.gov More Nicotine Dependence trials