Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218465
Status:
COMPLETED
Last Update Posted:
2017-03-24
First Post:
2005-09-16
Brief Title:
Effectiveness of GW468816 an NMDA Glycine Site Antagonist for Prevention of Relapse to Smoking
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Trial of the NMDA Glycine Site Antagonist GW468816 for Prevention of Relapse to Smoking
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Smoking is the leading cause of preventable mortality in developed countries Pharmacotherapy including bupropion and nicotine replacement therapy NRT is universally recommended for smoking cessation treatment however even with treatment the majority of smokers either fail to quit in the short term or relapse in the first year The high failure rate reported for smoking cessation then presents a challenge to explore innovative approaches to treating relapse to smoking
The purpose of this study then is to evaluate the efficacy of the glycine antagonist GW468816 compared with placebo on duration of abstinence and rates of relapse in female outpatient smokers during a randomized double-blind five-week clinical trial
To do this the investigators will conduct a two-phase study in which 300 adult female outpatient smokers will be enrolled
Phase I will consist of an 8-week smoking cessation study in which nicotine replacement therapy NRT and a behavioral intervention are openly administered on a tapered schedule Participants who are able to quit smoking after 7 weeks in this preliminary study will then be eligible to enter Phase II
Phase II is a 5-week double-blind placebo-controlled relapse prevention trial with the investigational medication GW468816
Participants in the Phase I smoking cessation study will begin by receiving nicotine replacement therapy in the form of the patch and brief support to stop smoking Participants will be required to schedule office visits every 1-2 weeks throughout Phase I
Subjects who are abstinent at the end of Phase I will be eligible to continue Phase II in which they will be randomly assigned by chance to receive the investigational medication GW468816 at 200 mg or placebo a pill that looks exactly like the study drug but contains no active drug Participants will be required to schedule weekly office visits throughout Phase II
Subjects who complete the 15-week trial both Phases I and II will enter the 6-Month Follow-Up to evaluate rates of long term abstinence from nicotine They will have office visits at Weeks 20 24 28 32 36 and 40 after discontinuation of study medications
Participants who enter the study will be offered the opportunity to participate in an ancillary neuroimaging study of mechanisms and surrogate markers of relapse that includes BOLD fMRI and MR spectroscopy to be carried out at the McLean Brain Imaging Center
The purpose of this study then is to evaluate the efficacy of the glycine antagonist GW468816 compared with placebo on duration of abstinence and rates of relapse in female outpatient smokers during a randomized double-blind five-week clinical trial
To do this the investigators will conduct a two-phase study in which 300 adult female outpatient smokers will be enrolled
Phase I will consist of an 8-week smoking cessation study in which nicotine replacement therapy NRT and a behavioral intervention are openly administered on a tapered schedule Participants who are able to quit smoking after 7 weeks in this preliminary study will then be eligible to enter Phase II
Phase II is a 5-week double-blind placebo-controlled relapse prevention trial with the investigational medication GW468816
Participants in the Phase I smoking cessation study will begin by receiving nicotine replacement therapy in the form of the patch and brief support to stop smoking Participants will be required to schedule office visits every 1-2 weeks throughout Phase I
Subjects who are abstinent at the end of Phase I will be eligible to continue Phase II in which they will be randomly assigned by chance to receive the investigational medication GW468816 at 200 mg or placebo a pill that looks exactly like the study drug but contains no active drug Participants will be required to schedule weekly office visits throughout Phase II
Subjects who complete the 15-week trial both Phases I and II will enter the 6-Month Follow-Up to evaluate rates of long term abstinence from nicotine They will have office visits at Weeks 20 24 28 32 36 and 40 after discontinuation of study medications
Participants who enter the study will be offered the opportunity to participate in an ancillary neuroimaging study of mechanisms and surrogate markers of relapse that includes BOLD fMRI and MR spectroscopy to be carried out at the McLean Brain Imaging Center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IND 74964 | OTHER | IND Number | httpsreporternihgovquickSearchU01DA019378 |
| U01DA019378 | NIH | None | None |