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Relapse Prevention Study in Newly Abstinent Smokers

Primary Purpose

Substance Dependence

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GSK598809
Nicotine Replacement Transdermal Patch
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Dependence focused on measuring nicotine dependence, smoking, pharmacological treatment, relapse prevention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Arm

GSK598809 Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Continuous smoking abstinence

Secondary Outcome Measures

safety endpoints including vital signs, weight, ECGs, safety laboratory test and adverse events
Weekly point prevalence abstinence
drug exposure level

Full Information

First Posted
November 18, 2008
Last Updated
February 11, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00793468
Brief Title
Relapse Prevention Study in Newly Abstinent Smokers
Official Title
A Study to Investigate the Effects of GSK598809 in Newly Abstinent Nicotine-dependent Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Study halted prior to enrollment of patients
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Dependence
Keywords
nicotine dependence, smoking, pharmacological treatment, relapse prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16.
Arm Title
GSK598809 Arm
Arm Type
Experimental
Arm Description
Subjects in GSK598809 arm will be taking GSK598809 once daily for 12 weeks from weeks 5 to 16.
Intervention Type
Drug
Intervention Name(s)
GSK598809
Intervention Description
GSK598809 once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Nicotine Replacement Transdermal Patch
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily for 12 weeks
Primary Outcome Measure Information:
Title
Continuous smoking abstinence
Time Frame
weeks 13 through 16
Secondary Outcome Measure Information:
Title
safety endpoints including vital signs, weight, ECGs, safety laboratory test and adverse events
Time Frame
weeks 1 through 16 and follow-up phase
Title
Weekly point prevalence abstinence
Time Frame
Weeks 6, 8, 10, 12, 14, and 16
Title
drug exposure level
Time Frame
weeks 6-16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
GSK Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
GSK Investigational Site
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
GSK Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
GSK Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
GSK Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
GSK Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
GSK Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Relapse Prevention Study in Newly Abstinent Smokers

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