Relapse Prevention Study in Newly Abstinent Smokers

GlaxoSmithKline (GSK)

Status and phase: Withdrawn; Phase 2

Conditions: Substance Dependence

Treatments: Drug: Nicotine Replacement Transdermal Patch; Drug: Placebo; Drug: GSK598809

Study type: Interventional

Funder types: Industry

Identifiers

NCT00793468

108428

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Placebo Arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: GSK598809

Drug: Nicotine Replacement Transdermal Patch

GSK598809 Arm

Experimental group

Description:

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

Treatment:

Drug: GSK598809

Drug: Nicotine Replacement Transdermal Patch