Relapse Prevention Study in Newly Abstinent Smokers

Phase 2

Withdrawn

• Conditions: Substance Dependence
• Interventions: Drug: GSK598809; Drug: Nicotine Replacement Transdermal Patch; Drug: Placebo

• Registration Number: NCT00793468
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Study Timeline

• Study First Submitted: 2008-11-18
• Study First Submitted QC: 2008-11-18
• Study First Posted: 2008-11-19
• Study Start: 2008-12
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	GSK598809	Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16.
Placebo Arm	Placebo	Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16.
GSK598809 Arm	GSK598809	Subjects in GSK598809 arm will be taking GSK598809 once daily for 12 weeks from weeks 5 to 16.
Placebo Arm	Nicotine Replacement Transdermal Patch	Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16.
GSK598809 Arm	Nicotine Replacement Transdermal Patch	Subjects in GSK598809 arm will be taking GSK598809 once daily for 12 weeks from weeks 5 to 16.

Primary Outcome Measures

Name	Time	Method
Continuous smoking abstinence	weeks 13 through 16

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Dallas, Texas, United States