Relapse Prevention Study in Newly Abstinent Smokers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2008-12-31

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.

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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.

Conditions

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Substance Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo Arm

Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16.

Group Type PLACEBO_COMPARATOR

GSK598809

Intervention Type DRUG

GSK598809 once daily for 12 weeks

Nicotine Replacement Transdermal Patch

Intervention Type DRUG

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.

Placebo

Intervention Type DRUG

Placebo once daily for 12 weeks

GSK598809 Arm

Subjects in GSK598809 arm will be taking GSK598809 once daily for 12 weeks from weeks 5 to 16.

Group Type EXPERIMENTAL

GSK598809

Intervention Type DRUG

GSK598809 once daily for 12 weeks

Nicotine Replacement Transdermal Patch

Intervention Type DRUG

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.

Interventions

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GSK598809

GSK598809 once daily for 12 weeks

Intervention Type DRUG

Nicotine Replacement Transdermal Patch

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.

Intervention Type DRUG

Placebo

Placebo once daily for 12 weeks

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No