Relapse Prevention Study in Newly Abstinent Smokers

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Substance Dependence
• Intervention / Treatment: Drug: Placebo; Drug: GSK598809; Drug: Nicotine Replacement Transdermal Patch

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Deland, Florida, United States, 32720
      • GSK Investigational Site
    • Pembroke Pines, Florida, United States, 33024
      • GSK Investigational Site
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • GSK Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • GSK Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • GSK Investigational Site
  • New York
    • Rochester, New York, United States, 14609
      • GSK Investigational Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • GSK Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • GSK Investigational Site
  • Texas
    • Dallas, Texas, United States, 75234
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Arm; Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16.	Drug: Placebo; Placebo once daily for 12 weeks; 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.
Experimental: GSK598809 Arm; Subjects in GSK598809 arm will be taking GSK598809 once daily for 12 weeks from weeks 5 to 16.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Continuous smoking abstinence	weeks 13 through 16

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Anticipated): December 1, 2008

Study Registration Dates

• First Submitted: November 18, 2008
• First Submitted That Met QC Criteria: November 18, 2008
• First Posted (Estimate): November 19, 2008

Study Record Updates

• Last Update Posted (Estimate): February 15, 2016
• Last Update Submitted That Met QC Criteria: February 11, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: relapse prevention; smoking; nicotine dependence; pharmacological treatment
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 108428