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Relapse Prevention Study in Newly Abstinent Smokers

NCT00793468 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-02-15

No results posted yet for this study

Summary

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.

Conditions

  • Substance Dependence

Interventions

DRUG

GSK598809

GSK598809 once daily for 12 weeks

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.

DRUG

Placebo

Placebo once daily for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00793468 on ClinicalTrials.gov