NCT00793468

Relapse Prevention Study in Newly Abstinent Smokers

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Substance Dependence

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-12-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-11-19
• Last updated: 2016-02-15

Locations

10 sites across 1 country: United States