Relapse Prevention Study in Newly Abstinent Smokers

GlaxoSmithKline

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Substance Dependence

Interventions

GSK598809DRUG

GSK598809 once daily for 12 weeks

Nicotine Replacement Transdermal PatchDRUG

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.

PlaceboDRUG

Placebo once daily for 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (10)

GSK Investigational Site

DeLand, Florida, United States

GSK Investigational Site

Pembroke Pines, Florida, United States

GSK Investigational Site

Stockbridge, Georgia, United States

Outcomes

Primary Outcomes

Continuous smoking abstinence

Time frame: weeks 13 through 16

Secondary Outcomes

safety endpoints including vital signs, weight, ECGs, safety laboratory test and adverse events

Time frame: weeks 1 through 16 and follow-up phase

Weekly point prevalence abstinence

Time frame: Weeks 6, 8, 10, 12, 14, and 16

drug exposure level

Time frame: weeks 6-16

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.