Relapse Prevention Study in Newly Abstinent Smokers

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of GSK598809 as compared to placebo in preventing recently-quit smokers from going back to smoking.

Detailed Description
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The primary objective of this study is to evaluate the efficacy of GSK598809 compared to placebo for the prevention of relapse to smoking in recently abstinent smokers. Subjects who meet eligibility criteria will enter a 4-week open label treatment period during which they will receive nicotine replacement therapy (NRT). Subjects who have achieved at least one week of abstinence during the last week of an open label treatment period will be randomized to either GSK598809 or placebo in the double-blind treatment period and followed for another 12 weeks.

Official Title
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A Study to Investigate the Effects of GSK598809 in Newly Abstinent Nicotine-dependent Subjects.

Conditions
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Substance Dependence

Intervention / Treatment
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* Drug: GSK598809
* Drug: Nicotine Replacement Transdermal Patch
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: has smoked at least 10 cigarettes a day for at least 2 years has had multiple previous attempts to quit smoking and relapsed to smoking. generally healthy Exclusion Criteria: cannot be using smokeless tobacco of any type or has tried to quit with medicine. does not abuse alcohol or drugs certain emotional problems being treated with medications pregnant or breast feeding female

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Arm<br>Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16. | Drug: GSK598809<br>* GSK598809 once daily for 12 weeks<br>Drug: Nicotine Replacement Transdermal Patch<br>* All subjects will be treated during the 4 week open-label smoking cessation phase of the study. During Weeks 1-3, subjects will receive 21mg/day, and during Week 4, subjects will receive 14 mg/day. Those subjects who reached continuous abstinence on at least week 4 of the open-label phase will receive 7mg/day during Week 5 while taking GSK598809 or placebo.<br>Drug: Placebo<br>* Placebo once daily for 12 weeks<br>|
| Experimental: GSK598809 Arm<br>Subjects in GSK598809 arm will be taking GSK598809 once daily for 12 weeks from weeks 5 to 16. | Drug: GSK598809<br>* GSK598809 once daily for 12 weeks<br>Drug: Nicotine Replacement Transdermal Patch<br>* All subjects will be treated during the 4 week open-label smoking cessation phase of the study. During Weeks 1-3, subjects will receive 21mg/day, and during Week 4, subjects will receive 14 mg/day. Those subjects who reached continuous abstinence on at least week 4 of the open-label phase will receive 7mg/day during Week 5 while taking GSK598809 or placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous smoking abstinence |  | weeks 13 through 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety endpoints including vital signs, weight, ECGs, safety laboratory test and adverse events |  | weeks 1 through 16 and follow-up phase | 
| Weekly point prevalence abstinence |  | Weeks 6, 8, 10, 12, 14, and 16 | 
| drug exposure level |  | weeks 6-16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nicotine dependence, smoking, pharmacological treatment, relapse prevention